Manager Clinical Research Operations

Responsible for oversight and coordination of MCRN clinical trials that are managed by the MCRN CRO. Responsible for working with data management, database management support, Angiographic Core Lab and Clinical trials team.

Minimum Qualifications

• Education: Masters Degree in Healthcare field or Life Sciences preferred
• Experience: Ten years experience in Phase I-IV clinical trials and knowledge of medical field. Strong knowledge of CRO structure and processes. Previous management experience. Excellent working knowledge of FDA, ICH, GCP and other regulatory functions. Proficiency with basic computer programs and exposure to Access, Visual Basic and other relational databases. Must possess excellent writing skills and ability to communicate effectively with staff and management.

Primary Duties and Responsibiliites

1. Manage all administrative functions of the CRO, including coordination of staffing and scheduling of day to day activity.
2. Writing protocols (clinical trial) and clinical trial design in Investigator initiated studies.
3. Solicitation of Industry support for Investigator initiated studies for the CRO,
4. Solicitation of ancillary sites other than MWHC for MCRN Investigator initiated studies for the CRO
5. Development of Manuals of Operations and Statistical Analysis Plans and collaboration with Data Coordinating Center in Case Report Form design.
6. Manage Contracts and Regulatory in budget development and contract terms for the CRO.
7. Support MCRN Research Fellows’ projects, abstracts and paper submissions.
8. Preparation of IDEs and INDs to support investigator sponsored studies.
9. Manage MCRN and Industry sponsored multi-center studies, including clinical trial design, protocol development, regulatory processes and monitoring of Institute’s compliance with Good Research Practices as it relates to the CRO
10. Manage data, queries and statistical analysis a well as required regulatory reports for all clinical databases in conjunction with MCRN Data Coordinating Center.
11. Manage and oversee the production of final reports for the MCRN CRO
12. Support requests for abstracts and manuscript submissions. Support management of the preparation of abstract/manuscript submissions or presentations at national meetings.
13. Participate in the Clinical Events Committee, Data Safety Monitoring Board meetings and all mandatory MCRN meetings.
14. Review monthly financial reports for accuracy and prepare other reports as needed. Responsible for the budget of the CRO studies under purview.
15. Support the design, development and implementation of additional databases for the EP, CHF and the other scientific leads in MCRN.
16. Hire and manage staff hired for the CRO activities
17. Participate in all mandatory MedStar Health Research Institute and MCRN meetings.
18. Interface with FDA/IRB and regulatory bodies on investigator initiated studies
19. Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
20. Perform other duties as assigned.