Research Program Administrator/director

vor 1 Monat

Landstuhl, Deutschland Decypher Vollzeit

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.

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