Clinical Research Project Manager

3 weeks ago

Bethesda, United States Kelly Full time

Kelly Government Solutions is seeking an experienced individual to work as a Clinical Research Project Manager (QC & Recruitment/Outreach) at the National Institutes of Health in Bethesda, MD. This role will require work to be performed on the NIH campus in Bethesda, MD.


TASKS

(1) Provide support in quality control review and clinical operations outreach to ensure compliance within protocol/research standards specific to clinical trial development, recruitment, outreach, and research data collection, and general clinical operations with use of the Clinical Trials Program (CTP) Quality Management System (QMS)

(2) Actively contribute to the accurate retention of complex clinical data and records by acting as Quality Control and Clinic Outreach Liaison

(3) Ensure adherence to International Commission on Harmonization (ICH), Good Clinical Practice (GCP), and Code of Federal Regulations (CFR).

(4) Ensure clinical notes adhere to protocol requirements, accurate input of clinical data and records information, aligning database cross-communications to secure data integrity.

(5) Verify that trial data is consistent with patient clinical notes and other source documentation

(6) Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.

(7) Audit research records, source documentation and practices to monitor compliance with applicable regulations. Identify areas of potential risk through audit processes, as well as assist with presentation of audit findings and design and monitoring of necessary corrective action.

(8) Identify training opportunities based on audits, design and present such education to prevent repeated compliance risks.

(9) Work closely with safety office team and research nurses/study coordinators to oversee the data management process.

(10) Perform monitoring support and quality control (QC) checks on all trials as needed

(11) Perform internal QC monitoring visits to ensure research data accuracy, consistency, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.

(12) Assist in the overall recruitment and pre-screening effort of the team in accordance with each protocol utilizing Vaccine Research Center (VRC) screening process criteria, in person or by telephone.

(13) Schedule participant screening visits in the VRC scheduling database; collect and enter initial pre-screening health and demographic information in database by interviewing subjects to determine protocol eligibility

(14) Assist with and participate in community engagement (in a variety of settings including college campuses, community events, and community-based organizations) and study recruitment plans/strategies, to include marketing, community outreach, health education, etc. for all VRC clinical research studies in order to increase enrollment and name recognition

(15) Assist in the development of recruitment materials such as data sheets, brochures, pre-screening documents, advertisement and other materials as appropriate for each engagement.

(16) Assist team members with the day-to-day clinical administrative ops tasks, such as copying, filing and clinical data entry; maintain tools and supplies to ensure proper recruitment for research studies.


REQUIREMENTS

(1) Bachelor’s degree in a related field.

(2) Minimum of two (2) years of experience in clinical research.

(3) Strong organizational and communication skills with demonstrated ability to simultaneously manage multiple projects.

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