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Employment Opportunities
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Click here to contact Synteract about a job.
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Administrative Assistant
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In this position, you will provide administrative support to the Project Management department to relieve senior personnel of administrative duties, whereby increasing their effectiveness. In support of clinical studies, you will assist with such tasks as maintaining the regulatory document collection database and the study payment database; contribute to start-up document development; facilitate clinical supply shipments, ensure filing of study documents, update study related lists (i.e., visit schedules/screening and randomization), and provide copying of documents, and other study related processes. You may prepare correspondence, spreadsheets and presentations utilizing MS Office, process invoices and expense reports, coordinate travel arrangements, arrange catering for department/client luncheons as necessary. You will execute special projects, which may require analyzing problems, determining approach, contacting internal and external resources to gather information, compiling and analyzing data, preparing reports and making recommendations.
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Qualified candidates will have a high school diploma or general education degree (GED) and 3 - 5 years relevant experience; industry experience highly desirable. Requires demonstrated proficiency in MS Word, Excel, and PowerPoint, and some knowledge of Access or similar database. Must be highly energetic for this fast paced environment; possess a customer service demeanor; demonstrates flexibility, teamwork, and a keen attention to detail.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Biostatistician
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| In this position, you will perform the data analysis for assigned clinical studies in which you
maintain the full-scope of responsibility; ensure on-time delivery, communicate the status of projects to internal
teams and study sponsors, execute quality assurance procedures on work produced by others and ensure programming is
being done according to specifications. Additional tasks include; to create/maintain analyses, tables/listings/graphs,
generally using SAS; to write/review Statistical Analysis Plan (including Mock tables/listings); to review
Case Report Forms to ensure data is collected appropriately to achieve the analysis defined in the protocol;
to create/QC specifications for, and program, derived data sets; and to perform programming validation/QC.
Additionally, you will assist in writing and/or reviewing Statistical Reports; review protocol, providing feedback
as well as adding to the methods section; provide sample size documentation; generate Randomization Schedules; and
work closely with sponsor to ensure a high quality, timely delivery of tables/listings and statistical reports.
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| Qualified candidates will have a Master's degree or equivalent in statistics or related field
of study and 3-5 years relevant experience, or equivalent combination of education and experience. Requires intermediate
proficiency with SAS, SPSS, or other statistical software, Microsoft Word and Excel, Outlook and Internet Explorer.
Must be an analytical thinker; possess a customer service demeanor; demonstrate attention to detail, teamwork, flexibility,
the ability to plan and organize and to meet scheduled timelines. |
| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Data Manager
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| In this position, you will be responsible for managing the
clinical trial data for assigned projects, acting as the liaison between
Synteract personnel and the study sponsor to implement and maintain clinical
databases. You will design, or direct the design of, a Case Report Form (CRF)
for data collection; develop a data management plan and QA program, which will
be approved by the sponsor; design, or direct the design of, an efficient
logical database using Synteract standards or the Sponsor's specifications,
which can be exported efficiently into SAS; define, check, and document logical
edit checks for data quality control; develop, maintain and document data entry
guidelines and data conventions. You may perform SAS Programming of edit
checks, metrics, and ad-hoc data management listings; perform QC of database
structure, develop data transfer agreements and specifications working with
outside electronic data vendors; perform QC review of SAS programs.
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| Qualified candidates will possess a Bachelor's degree or
equivalent in a life science, nursing, mathematics, computer science or related
field of study and a minimum of 3 years relevant experience or equivalent
combination thereof. SAS programming experience in SAS/BASE, SAS/CORE is highly
desirable as is experience with relational databases, i.e., Oracle. Requires
intermediate proficiency in Microsoft Word, Excel, PowerPoint, and Access or
similar database software. May require basic proficiency in JAVA, C++, or
Visual Basic programming. Must possess a customer service demeanor; must
demonstrate a strong sense of urgency, teamwork, keen attention to detail, the
ability to plan and organize and to multi-task. |
| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Data Processor
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| In this position, you will perform clinical data entry and validation to ensure legibility, completeness, and accuracy of data; track Case Report Forms and other clinical documents upon receipt, assist in the quality control of data by reviewing patient profiles, flag and make note of any illegible, misspelled or out of field length data, assist the department with copying, stamping and filing. |
Qualified candidates will have a high school diploma or general education degree (GED). Some experience desired, but not required. Requires basic proficiency in both Microsoft Word and Microsoft Excel, and excellent spelling and grammar skills. Must posses a professional demeanor; demonstrate teamwork, flexibility, and attention to detail. Employment is initially of temporary status, conditional upon the volume of work provided by Synteract clients, along with ones ability and skill level to perform the necessary tasks associated with our client needs.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Programmer Analyst II/Senior
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| In this position, you will provide computer programming in support of clinical studies. You will maintain the full-scope of responsibility for assigned projects: ensure on-time delivery, communicate the status of projects to internal teams and study sponsors, execute quality assurance procedures on work produced by others and ensure programming is being done according to specifications. You will create/maintain analyses, tables/listings/graphs, generally using SAS; create specifications for, and programs, derived data sets; perform programming validation/QC; provide ad-hoc reports as requested; assist in programming edit checks; and work with sponsor/statistician to write/review Statistical Analysis Plan, including mock tables/listings. |
| Qualified candidates will have a Bachelor's degree or equivalent in mathematics, statistics, or related field of study and 2+ years? relevant experience, which includes comprehension of GCP and other industry relevant guidelines. Intermediate/Advanced knowledge of SAS, SPSS, or other statistical software required. Must be an analytical thinker; possess a customer service demeanor; demonstrate attention to detail, teamwork, flexibility, the ability to plan and organize and to meet scheduled timelines. |
| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Project Manager
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| In this position, you will serve as the primary interface with client representatives as well as Synteract personnel to ensure the timely initiation and completion of clinical trials. You will prepare proposals, budgets and contracts; interact with applicable pharmaceutical, biotechnology clients and Synteract vendors to ensure that all contractual obligations are met; ensure adequate resource requirements; coordinate initial client meeting identifying project objectives; develop Project Management plan to include timeline and milestones; coordinate Project Team Meetings, including development of meeting agendas and minutes; conduct daily, on-going communication via telephone and email, responding to inquiries and client requests; manage budget throughout the duration of the project and develop out of scope documentation and costs. |
| Qualified candidates will have a Bachelor's degree, or equivalent, in a related field of study and a minimum of 5 years' pharmaceutical or biotechnology clinical research experience. Requires working knowledge of GCPs, ICH guidelines and FDA regulations. Must possess a professional demeanor, a customer service demeanor; demonstrate problem solving, a strong sense of urgency, keen attention to detail, and the ability to plan and organize. |
| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Research Associate II - North Carolina
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Based in our new Morrisvilee, North Carolina, office, you will perform the on-site monitoring of clinical studies. You will assist in the identification of potential clinical investigators and evaluate qualifications of investigators and site personnel; determine if facilities are adequate based upon protocol requirements; monitor Case Report Forms (CRFs) for trends in safety and ensure the timely reporting of adverse events and study progress; monitor ongoing clinical research by maintaining close communication with study investigators and by inspection of study site records to verify data validity and to ensure compliance with the protocols, federal regulations, SOPs and GCPs; motivate sites to complete study enrollment and follow-up visits within projected timelines; ensure stock of clinical supplies is sufficient to meet study needs; ensure availability of all final study documentation in anticipation of a Sponsor or FDA audit. Will travel more than 60 - 70% within the designated East Coast territory.
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Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent and a minimum of 2 - 4 years' relevant experience, to include 2 years monitoring experience. Certified Clinical Research Associate certificate desired, not required. Valid driver's license is required. Requires working knowledge of GCPs, ICH guidelines and FDA regulations. Must possess a professional demeanor. Must be able to work independently, to effectively manage multiple priorities, to effectively provide instruction and coaching to site personnel, and to identify, communicate and resolve issues identified. Must demonstrate teamwork and keen attention to detail.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Clinical Research Associate II/In-house - California
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As an "In-House" Clinical Research Associate (CRA) you will assist in all aspects of clinical trials management, including initiating, investigating and monitoring of clinical studies.
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You should have a Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent and a minimum of 3 years' monitoring experience. Certified Clinical Research Associate certificate a plus. Requires working knowledge of GCPs, ICH guidelines and FDA regulations. May travel up to 25%.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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CRF Designer I |
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In this position, you will be responsible for the development, design and production of Case Report Forms (CRFs). You will collaborate with project teams to plan, analyze, organize and execute assigned projects; provide input on the development of Case Report Forms and ancillary documentation; design the aesthetics and layout of CRFs and ancillary documentation; create global CRFs in compliance with Synteract standards and processes, quality and timelines using Framemaker software; enforce current and legacy standards that support the software; collaborate with Data Management to ensure CRF revisions are provided to team members, provide status updates and ensure all requested changes are complete; and build/maintain book files for current projects. You will also coordinate the review and revision of procedures, specifications and forms.
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Qualified candidates will possess an Associate's degree (A. S.) or equivalent from a two-year college or technical school and a minimum of 2 years related experience, or equivalent combination of education and experience. Requires basic proficiency in graphic design, specifically Adobe Framemaker and Adobe Acrobat software. Must have the ability to comprehend basic medical terminology and clinical trial protocols. Intermediate proficiency in both Microsoft Word and Microsoft Excel required. Must possess a customer service demeanor; must demonstrate a strong sense of urgency, teamwork, keen attention to detail, and the ability to plan and organize and to multi-task.
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| Contact: To apply for this position, please email your resume to Synteract Jobs. |
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Drug Safety Associate- California
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| In this position, you will receive and analyze Serious Adverse
Event (SAE) information for completeness, accuracy and regulatory reportability
requirements; evaluate SAE case data with an emphasis on medical presentation,
conduct discussions regarding specific patient case data with health care
practitioners and Sponsors; determine regulatory reporting requirements based upon
case data, product information, and FDA or ICH guidelines and regulations; prepare
SAE Reports, including preparation of narrative summary; identify missing/discrepant
data, write queries, address queries with site personnel, evaluate query responses,
and resolve queries when complete. Additionally, you will maintain the SAE database
and perform coding of adverse event terms and concomitant medications.
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| Qualified candidates will have a Bachelor's degree in nursing
(B.S.N.), Registered Nurse (R.N.), or Doctor of Pharmacy and 3-5 years' relevant
experience. Requires in-depth knowledge of medical terminology and of GCPs, ICH
guidelines and FDA regulations with an emphasis on safety. Must posses a
professional demeanor; demonstrate initiative, sense of urgency, ability to organize
and prioritize, and keen attention to detail.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Drug Safety Associate- North Carolina
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| In this position, you will receive and analyze Serious Adverse
Event (SAE) information for completeness, accuracy and regulatory reportability
requirements; evaluate SAE case data with an emphasis on medical presentation,
conduct discussions regarding specific patient case data with health care
practitioners and Sponsors; determine regulatory reporting requirements based upon
case data, product information, and FDA or ICH guidelines and regulations; prepare
SAE Reports, including preparation of narrative summary; identify missing/discrepant
data, write queries, address queries with site personnel, evaluate query responses,
and resolve queries when complete. Additionally, you will maintain the SAE database
and perform coding of adverse event terms and concomitant medications.
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| Qualified candidates will have a Bachelor's degree in nursing
(B.S.N.), Registered Nurse (R.N.), or Doctor of Pharmacy and 3-5 years' relevant
experience. Requires in-depth knowledge of medical terminology and of GCPs, ICH
guidelines and FDA regulations with an emphasis on safety. Must posses a
professional demeanor; demonstrate initiative, sense of urgency, ability to organize
and prioritize, and keen attention to detail.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Manager, Clinical Operations
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In this position, you will be responsible for the overall coordination of the Clinical Research Associate (CRA) team and monitoring of daily activities to ensure the successful completion of clinical trials. Participates in the planning, implementation, monitoring and management of clinical trials in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and SOPs. You will be the Primary interface with Client representatives as well as Synteract personnel in the Project Management, Data Management, and Biostatistics departments to ensure the timely initiation and completion of clinical trials; coordinate the activities of employee and contract CRA team members; designate site assignments, track and review monitoring reports and calendars; Ensure CRA resources and other project resources are continuously adequate; interviews and selects CRA?s for studies; ensure standards for monitoring and reporting are met; coordinate study specific training and other requirements for internal and external staff; mentor and train CRAs in clinical study monitoring and the relevant federal regulations, ICH Guidelines and GCPs.; In conjunction with the Project Manager, you will interact with applicable pharmaceutical, biotechnology clients and Synteract vendors to ensure that contractual obligations related to clinical activities are met; participate in initial client meeting identifying clinical study objectives; review clinical documents such as monitoring plans, clinical SOPs and guidelines; manage clinical budget throughout the duration of the project and develops out of scope documentation and costs.
Qualified candidates will posses a Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent and 7-10 years relevant experience. Certified Clinical Research Associate certificate desired, but not required. Must be able to demonstrate experience in monitoring and in developing study-related documents. In-depth knowledge of GCPs, ICH guidelines and FDA regulations. Must possess a professional demeanor; be able to manage conflicting priorities, delegate effectively, and communicate effectively.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Medical Coding Specialist |
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In this position, you will be responsible for the medical coding and medical review of clinical data. Works closely with the data management project team, clinical project team, safety surveillance team and study sponsor to ensure that medical logic and consistency are maintained throughout the collection of data for the clinical trial. You will perform coding of medical events (e.g. adverse events, medical history, procedures, concomitant medications, physical exam) relative to each other in order to ensure medical logic and consistency; ensure all medical issues relative to the clinical database are addressed with the Data Manager; respond to the needs of the other members of the study team (clinical, statistical analysis etc.) as directed by the Data Manager; update the coded SAS database when necessary; and produce any reports required during the course of study.
Qualified candidates will have a nursing degree (B.S.R.N.), related license, or clinical experience and a minimum of 2 years coding experience, or equivalent combination of education and experience. Must be conversant in medical terminology. Must possess a professional demeanor, a customer service demeanor, and demonstrate teamwork, flexibility, adaptability and attention to detail.
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| Contact: To apply for this position, please email your resume to Synteract Jobs. |
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Programmer Analyst, SQA |
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In this role, the Programmer Analyst will focus on the testing and development of Interactive Voice-Response (IVR) and Interactive Web Response (IWR) systems used to manage clinical trials. Will be responsible for developing test plans, including test cases and test data, overseeing test execution, and performing study-level and system-level validation. Development tasks may include creating design specifications, project-related programming and database setup. Will provide project and technical support. Periodic after-hours support may be required. Primary Responsibilities: Perform code reviews Develop test plans & test cases Programming, testing and validation of Interactive Voice Response and Interactive Web Response systems. Manage test execution including the scheduling of business and technical resources required to support the testing. Providing technical support to project teams and clients. Creating auditable documentation trail. Record, report, and track defects to accurately report the status of testing to the project team. Development of user manuals and instruction guides.
Requires a B.S. in computer science or related field of study and a minimum of 2 years? relevant work experience. Experience in software documentation review, writing and implementing test plans, writing and executing manual system level test cases and procedures required. Must have experience coordinating all aspects of software testing, developing test plans, matrixes, cases, scripts, data, etc. Requires demonstrated knowledge of Oracle or SQL Server, proficiency with one or more high level programming languages and knowledge of SQL, PL/SQL or Transact SQL. Knowledge of IVR and telephony is a plus. Experience testing and developing software in a quality controlled environment or clinical trials field is preferred. The ideal candidate will possess knowledge of the software development life cycle, FDA/ISO regulations for software development, and have experience in software testing and test automation.
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| Contact: To apply for this position, please email your resume to Synteract Jobs. |
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Receptionist
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| As the Receptionist, you will provide reception services to visitors and callers, and additionally provide clerical support to our various business units. You will greet visitors and notify appropriate employees of arrival; and issue visitor badges and maintain Visitor Log. You will maintain the front office ensuring a neat and professional appearance as well as upkeep the coffee stations. You will be responsible for maintaining the multi-line telephone system; checking voicemail messages daily and recording new greetings as necessary. Lastly, you will answer telephone calls into the main line and route accordingly; create and maintain employee mailboxes; receive mail delivery and fax transmittals and distribute accordingly; coordinate delivery and pick-up of overnight shipping services; prepare shipping labels as necessary; and ensure mailroom office supply inventory is adequate.
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| Qualified candidates will possess a high school diploma or general education degree (GED). Some clerical experience desired, not required. Basic proficiency in Microsoft Word, Excel, and PowerPoint a must. Must possess a customer service demeanor; must demonstrate a strong sense of urgency, teamwork, keen attention to detail, the ability to plan and organize and to multi-task. For immediate consideration, please send your resume or CV to jobs@synteract.com. Please reference ?Receptionist? in subject line when applying. Visit our website at www.synteract.com.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Senior Clinical Research Associate - California
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As the Sr. Clinical Research Associate (CRA) you will assist in all aspects of clinical trials management, including initiating, investigating and monitoring of clinical studies. Must be willing to travel 60 to 70%.
Positions require a Bachelor's degree in a life science, B.S.N., Registered Nurse, or equivalent and 3 to 7 years? monitoring experience. Certified Clinical Research Associate certificate a plus. Requires working knowledge of GCPs, ICH guidelines and FDA regulations.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Software Developer II
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As a Software Developer, you will assume a leading role in the development and implementation of new applications. You will define software specifications; program and code according to predefined user requirements and system specifications; produce well formatted code with detailed supporting documentation; design, develop, and test web and software applications; and develop validation and design documentation including Requirement Specifications, Design Documents, Flowcharts, E/R Diagrams, Installation Qualifications, Operation Qualification and Performance Qualification scripts. You may interact directly with clients and end users to gather requirements and discuss technical implementation processes.
Qualified candidate will possess a Bachelor's degree in Computer Science or related field (B.S.) and a minimum of 3 years relevant experience, or equivalent combination of education and experience. Advanced proficiency in one or more .NET programming languages and Visual Studio .NET integrated development environment a must. Intermediate proficiency with UNIX environments and scripting languages (Perl, UNIX, etc.) required. Must have proficiency in C/C++ and intermediate familiarity with .NET architecture. Proficiency with SQL and one of the following required: PL/SQL or Transact SQL.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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Sr. Clinical Data Programmer
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In this position, you will provide computer programming in support of clinical studies. You will maintain the full-scope of responsibility for assigned projects: ensure on-time delivery, communicate the status of projects to internal teams and study sponsors, execute quality assurance procedures on work produced by others and ensure programming is being done according to specifications. You will create/maintain analyses, tables/listings/graphs, generally using SAS; create specifications for, and programs, derived data sets; perform programming validation/QC; provide ad-hoc reports as requested; assist in programming edit checks; and work with sponsor/statistician to write/review Statistical Analysis Plan, including mock tables/listings.
Qualified candidates will have a Bachelor's degree or equivalent in mathematics, statistics, or related field of study and 2+ years? relevant experience, which includes comprehension of GCP and other industry relevant guidelines. Intermediate/Advanced knowledge of SAS, SPSS, or other statistical software required. Must be an analytical thinker; possess a customer service demeanor; demonstrate attention to detail, teamwork, flexibility, the ability to plan and organize and to meet scheduled timelines.
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| Contact: To apply for this position, please email your resume to
Synteract Jobs.
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- Patient Randomization
- Patient Scheduling
- Drug Inventory Control
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April 27-30, 2008
Ft. Lauderdale, Florida
Booth #304
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May 30 - June 3, 2008
Chicago, Illinois
Booth #23120
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June 22-25, 2008
Boston, Massachussetts
Booth #1503
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Synteract News
Synteract Attends DFUG
Presents at DFUG
Debuts SynCapture
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