Job description

Duties: The purpose of this position is to ensure the smooth functioning of investigator-initiated clinical trials, and Federal studies in accordance with all relevant regulations and guidelines. These duties will include assisting the Principal Investigator on daily research operations; conducting study monitoring and assisting with completion of annual reports per protocol; coordinate. complete and submit all IRB and other regulatory correspondence, supporting regular meetings of the DSMB; serving as primary contact for study operations and assist with study start-up and close-out activities. Participate in audits. Coordinate the day-to-day operations of clinical trials, including IRB, Industry Sponsors, NIH and FDA regulatory documentation. Implement all approved changes to procedures as needed and monitor results. Screen and recruit participants and determine eligibility of potential participants, obtain informed consent and administer study assessments.

Responsibilities include coordinating conduct of a study for a medication with an addiction population; recruiting, screening and enrolling eligible subjects; obtaining informed consent and administering baseline and follow-up interviews and questionnaires including TLFB and electronic entry; serving as back-up for scheduling participants using CalendarWiz to complete assessments with members of the study team as outlined in the study protocol. Complete and manage regulatory aspects of assigned trials including organizing and maintaining regulatory files for the study, ensuring data entry and query resolution per sponsor requirements, completing documents such as progress reports, IRB submissions and correspondence with sponsor, reporting of SAEs, etc.; completing CRFs; resolving regulatory queries; and attending relevant meetings including audits. Lab duties include processing and spinning specimens using centrifuges, preparing specimens per the protocol, as well shipping lab specimens and ordering dry ice. Additional responsibilities include but are not limited to supervising research staff and training new employees as needed, overseeing participant payments, meeting regularly with the Principal Investigator and study team to identify problems and develop solutions.

Qualifications: BA/BS with at least 2-4 years' experience, preferably in conducting industry sponsored clinical trials in addictions research and/or experience conducting treatment research in the addictions or other psychiatric disorders, or an equivalent combination of education and experience required. Candidate should have familiarity with performing research study assessments and diagnostic interviews in-person and over the phone with participants. Management skills, attention to detail in data collection, data entry in electronic databases and data management required. Must be available to accommodate participants for evening study visits required. Position contingent upon continued funding.

Reference Number: 40-28487

Salary Grade: 026

Employment Type: Exempt

Org: PS-Addictions

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: I-Technical/Professional Research




Diversity Profile: University



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Job No:
Posted: 4/11/2018
Application Due: 1/10/2019
Work Type: