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Research Program Administrator/director
vor 2 Wochen
Decypher is a leading integrator of professional, technology, and management solutions and services. We provide our services globally to Federal, Commercial, Local and State clients. Our employees are our most valuable asset and play an integral role in the success of Decypher and our clients. Working at Decypher is not a job, but a career where your talent and energy is respected, and you can personally make a difference. Decypher invites you to join our professional team. Decypher is an equal opportunity/affirmative action employer committed to diversifying its workforce (M/F/D/V).
DESCRIPTION
Decypher is seeking a Research Program Administrator/Director.
Core Duties:
Coordinates and assures integrity of all activities associated with conducting TBICoE
TBI clinical investigations as it relates to compliance with local, state, and/or federal
regulatory requirements.
- Assists Principal / Associate Investigators in the preparation and submission of clinical
protocols, consent forms and other documents to the scientific review committee, IRB
and other regulatory organizations.
- Prepares requests for actions/proposals to include assisting with and providing
requirements as needed. Facilitates the flow and approval processes for relevant projects
as needed or requested.
- Maintains regulatory files related to TBICoE clinical investigations.
- Communicates with research participants, staff, regulatory affairs, and data management
groups, laboratory and clinical investigators, management and outside collaborators.
- Recruits, interviews, and screens TBICoE clinical research study volunteers, administers
and obtains informed consent.
- Assists in the collection and analysis of data to evaluate volunteer eligibility for
enrollment.
- May assist with TBI Program/Quality Improvement initiatives at their site.
- Assists in the collection, analysis and interpretation of laboratory and clinical data
obtained during a medical evaluation, report significant values, findings and events that require prompt attention to clinical investigators.
- Assists with the documentation and reporting of adverse events, completes and reviews
- Participates in and supports, as required, Intrepid Network clinical care, research, and programs, initiatives, opportunities, and working groups including membership in the BOD Translational Research Advisorate
- Prepares and maintains written and electronic volunteer databases/logs.
- Performs data extraction and chart reviews of patients’ and/or research participant’s
medical records or other relevant record/systems, as applicable.
- Ensures that research records are stored and secured properly and that inventory and
records are updated and properly maintained.
- Conducts data verification as indicated, documents, assists the investigator and protocol
coordinator with questions, may transcribe and resolve queries of data on study forms
(hardcopy and/or electronic).
- Prepares documents, under direction of project leads. Trains incoming staff on study
procedures and SOPs.
- Assists with statistical analyses and descriptive data capture under direction of project
leads. Works with the site senior clinical research director and other senior research leads
for the collection, documentation and analysis of metrics to ensure a successful research
program.
- Other duties consistent with the above responsibilities
Minimum Qualifications:
- Degree: Bachelor's Degree or higher in biology, psychology, or related science.
- Education: Bachelor's Degree or higher in biology, psychology, or related science; Masters Degree preferred.
- Certification: Human Subjects training as well as Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP), or Clinical Research Associate (CCRA) certification.
- Experience: 3-5 years of experience with clinical investigations required; prior work in DoD or VA systems preferred.
