Research Compliance Associate
Job Description Summary:
I. JOB OVERVIEW
The Biostatistics Center (BSC) of the Milken Institute School of Public Health is an off-campus research facility of The George Washington University located in Rockville, Maryland. The Biostatistics Center serves as the coordinating center for large scale multi-center clinical trials and epidemiologic studies funded by the National Institutes of Health (NIH) and other Federal agencies. The Biostatistics Center is a leader in the statistical coordination of major medical research programs of national and international scope, frequently leading to major medical advances. Visit our website at: www.bsc.gwu.edu.
The NIH requires all multi-center studies to use a single IRB of record. In this position, the Research Compliance Associate will work on NIH funded clinical research studies conducted by the Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units (MFMU) Network. The successful candidate will coordinate all activities required by the single IRB of record including serving as the Point of Contact (POC) for the Lead Study Team. He/she will serve as the main person responsible for communication with the Reviewing IRB and facilitating communication between relying site study teams and the Reviewing IRB regarding the ceded study (ies).
Duties most typically performed by this position include utilizing relevant professional experience and judgment for the following:
-Prepares the study-wide application for initial IRB review and study-wide amendments to the Reviewing IRB.
-Responds promptly to questions or requests for information from Site Investigators and/or study teams at Relying Institutions or the Relying IRB.
-Obtains and collates information from Relying Site POCs regarding local variations in study conduct, such as recruitment materials and process, consent process and language, and subject identification processes.
-Ensures POCs at the Relying Institutions' consent documents follow the Reviewing IRB's template form and include applicable site-specific required language from each Relying Institution.
-Participates in conference calls regarding a study or attends study group meetings with project teams.
-Obtains and collates study-wide information for continuing review to the Reviewing IRB
-Reports reportable events to the Reviewing IRB.
-Reviews new adverse events entered into the online adverse event reporting system and distributes to study specific research teams.
-Provides participating Relying Site Study Teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials) in a timely manner.
-Notifies Site Investigators of all Reviewing IRB determinations and communications, including those for initial review, continuing review, amendments, and reportable events.
-Documents all new processes and procedures, as well as maintaining study documents and documentation of changes.
-Performs other work related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications:
-High level of accuracy and attention to detail; strong problem-solving skills
-Excellent organizational and communication (oral and written) skills
-Ability to work independently
II. JOB DETAILS
Campus Location: Rockville, Maryland College/School/Department: Biostats Family Research Administration Sub-Family Research Compliance Stream Individual Contributor Level Level 2 Full-Time/Part-Time: Full-Time Hours Per Week: 35 Work Schedule: Monday through Friday, 9am to 5pm Position Designation: Essential: Employees who perform functions that have been deemed essential to maintaining business or academic operations. Employees are generally expected to work from home during an event and may be asked to physically report to work. Telework: No Required Background Check: Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search Special Instructions to Applicants:
Employer will not sponsor for employment Visa statusInternal Applicants Only? No Posting Number: S007303 Job Open Date: 06/05/2018 Job Close Date: If temporary, grant funded or limited term appointment, position funded until: Background Screening Successful Completion of a Background Screening will be required as a condition of hire. EEO Statement:
The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.
Posting Specific Questions
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- Cover Letter
Documents needed to Apply
- Cover Letter