Coordinates research regulatory rules and processes for federal grants and pharmaceutical-funded clinical trials.
Coordinates with a variety of institutional review boards all required applications, submissions, responses, addenda, and reports.
Works very closely with the Director of Compliance and Legal Counsel on regulatory and contract reviews for new studies and amendments.
Negotiates contracts and budgets for clinical trials and with outside vendors.
Budgets will be negotiated within internal organizational guidelines and finalized by departmental leadership.
Tracks and create invoices for research-related procedures and study visits and deliverables that are to be reimbursed.
Liaise with study monitors and ensure support for their reviews of all materials during site visits.
Completes federal grant sub-award agreements with partner institutions.
Assists in organizing and submission of grant proposals with a variety of web-based portals.
Draft grant-related reports and monitor production and submission.
Submits funding deposits for the subject stipend system as needed, separating out payments by the study.
Knowledge, Skills, and Talents Required
Knowledge of research in general, clinical trials, and cohort studies in particular.
Demonstrated ability to work with multiple departments and outside collaborators.
Knowledge of general protocols for clinical research, specifically as relates to ethical standards for the conduct of human subjects research.
Highly developed oral and written communication skills, including the ability to function efficiently as part of a multidisciplinary team in facilitating the clinical trial programs.
Ability to prepare accurate, concise, and comprehensive reports.
Ability to maintain client records and information in an accurate, timely, and confidential manner.
Excellent organizational skills, including proficiency in the use of computer word processing, data entry, and Excel programs and the ability to handle multiple tasks simultaneously.
Education and Experience Required
Bachelor’s Degree in science or public health-related field required or clinical trial administration or at least eight years of direct clinical research experience with experience in research regulatory management. Graduate training preferred.
At least two years of Human Subjects or Clinical Trail Research experience required.
Thorough knowledge of research, grant management, and/or contract development.
Internal Number: 653
About Whitman-Walker Health
Whitman-Walker envisions a society where all persons are seen for who they are, treated with dignity and respect, and afforded an equal opportunity to health and wellbeing. Through care, advocacy, research, and education, we empower all persons to live healthy, love openly, and achieve equality and inclusion. For over 40 years, we have been meeting the needs of our communities with the endless dedication of our diverse teams.