Clinical Research Manager

Job Summary

Serves as Clinical Research Manager in the Department of Internal Medicine / Division of Benign Hematology; works conjunctively with the COM Center for Clinical Research Management (CCRM); participates in execution of clinical research activities in collaboration with site Principal Investigator(s); evaluates and implements designated aspects of new research strategies and protocol start-up; participates in developing and implementing processes to enroll patients to clinical trials to ensure consistency and integrity in eligibility determination, recruitment and subject management; collaborates with the CCRM to implement study participant consenting processes to comply with COM, sponsor and federal regulations; oversees and manages planning, implementation and execution of clinical trials within the Division of Benign Hematology; plans and supervises daily administrative, research and patient care activities of the clinical research staff; oversees clinical research staffs recruitment activity including, interviewing, screening and enrolling of patients into relevant protocols; assists with training and re-training of newly hired and current clinical research staff; supervises clinical research data collection, management, analysis and reporting; collaborates with investigators to develop research protocols and assists with writing and preparation of grant applications to obtain research funding; participates in writing and submission of manuscripts and articles for publication and presentation conducts quality assurance reviews of research processes and data; ensures compliance to federal, state and local regulations and guidelines; plans, coordinates and participates in site visits by research sponsors and regulatory agencies as needed; actively contributes to the COM and Department research initiatives.

Minimum Education Required

Bachelors Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.

Experience Required

5 years of relevant experience required. Knowledge of clinical research regulations, guidelines amp; compliance issues required including Institutional Review Board (IRB) amp; federal or industry sponsor processes and requirements.

Required Certification

ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required and must be maintained.

Preferred Experience and Skills

8-12 years of relevant experience preferred. Experience in a progressively responsible administrative or management research capacity preferred; supervisory experience preferred; knowledge of clinical trials data mgmt preferred; experience writing research grants and proposals strongly desired.

Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.

FUNCTION / SUBFUNCTION : Research and Scholarship / Clinical Research

CAREER BAND : People Leader- Managerial

CAREER LEVEL : M2