Join the HJF Team!
JOB SUMMARY: HJF is seeking a part-time, temporary Clinical Research Associate to support the Center for Neuroscience and Regenerative Medicine (CNRM) in Rockville, Maryland. Responsibilities include to monitor the execution of clinical trials associated with specific projects and to ensure that all necessary steps including safety and following regulations are being taken.
ESSENTIAL JOB DUTIES: 90% of time
1. Participates in site selection process.
2. Responsible for the management of CNRM Monitoring Plan for CNRM-funded protocols to include tracking of monitoring timelines, scheduling site monitoring visits, conducting site monitoring visits, and generating monitoring reports and letters.
3. Identifies needs for Site Initiation Visit (SIV) to include preparing and conducting protocol overview presentation, Good Clinical Practice (GCP) and Informed Consent trainings to the study team.
4. Ensures that regulatory documents are maintained and are up to date.
5. Reviews Case Report Forms for patient eligibility, protocol compliance, omissions, errors, etc. and files them as required.
6. Reviews the source document files for verification of critical variables, entrance criteria, visit dates, lab data, etc.
7. Ensures that research records and drugs are stored, secured properly, and have not expired.
8. Ensures that inventory and records are updated and properly maintained.
9. Conducts source documents review and verification in CNRM Data Repository.
10. Assists the investigator and protocol coordinator with questions associated with regulatory and protocol compliance. Provide ongoing training as needed.
11. Reviews and tracks Adverse Events (AE), Serious Adverse Events (SAEs), and major deviations.
12. Ensures all queries are addressed in the electronic Data Capturing System (EDC).
13. Conducts protocol Close-out visits and generates Close-out reports and letter.
14. If applicable, management of contracted monitoring services. Review all monitoring reports and advise on payment for related invoices.
15. Point of contact (POC) for all CNRM funded and collaborative protocol tracking, status updates, and associated documents.
16. Tracks protocol screening and enrollment data and generates CNRM Protocol Overview Report (POR) for CNRM Leadership reviews on a monthly basis
NONESSENTIAL JOB DUTIES: 10% of time
17. Provides other assistance to clinical sites as needed
Required Knowledge, Skills, and Abilities: Knowledge of PCs and Macintoshes; knowledge of human anatomy and physiology; ability to write progress reports in a clear and concise manner; excellent communication and interpersonal skills; ability to establish goals and agendas. Knowledge of Good Clinical Practice (GCP); previous experience with US Department of Defense funded research preferred.
Minimum Education/Training Requirements: Bachelor's degree in biology or related science
Minimum Experience: 6 to 8 years of clinical trial experience
Physical Capabilities: Frequent standing, sitting, walking, lifting, traveling
Required Licenses, Certification or Registration: n/a
Supervisory Responsibilities/Controls: n/a
Work Environment: Office/hospital environment. Domestic travel (including overnight travel) can be anticipated up to 20% of the time.
Background: This position requires US citizen ship and eligibility to obtain a Common Access Card (CAC).
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources