Clinical Research Manager - Obstetrics and Gynecology

The Medical College of Wisconsin•Milwaukee, WI

4d•Onsite

About The Position

Manage all aspects of gynecological oncology clinical trial initiatives to ensure compliance with state, federal and institutional regulations, policies and procedures. Primary Responsibilities Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research. Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards. Manage data systems supporting research activities. Correspond with IRBs as needed. Assist in the development and management of budget. Recruit and train clinical research staff nurses and/or clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Mentor and direct staff to achieve research goals. Coordinates planning, feasibility, and implementation of new protocols with research nurses, investigators, and multidisciplinary study teams. Maintains unit staffing needs by developing, implementing, and revising a staffing plan which assures efficient and effective delivery of participant care and facilitation of research studies during regular and after-hours clinical research visits. Under physician direction, perform protocol-specific clinical tasks including patient assessment, screening, ordering tests, collecting specimens, and monitoring responses. May administer medication or other types of protocol specific intervention. Act as a liaison between Department Administrator and research staff. Work closely with other departments and external agencies to advance the department’s research goals. Develop, implement and monitor department research QI activities. Implement and conduct quality control processes to ensure the highest data and research standards. Develop clinical review data review plan and check specifications. Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes. Other duties as assigned.

Requirements

Knowledge of biology, clinical judgment, medicine, cultural awareness, and consulting.
Medical documentation, interpersonal, practice-based learning and improvement, empathy, and decision making skills.
Forward and innovative thinking.
Bachelor’s degree.
6 years of experience.
Wisconsin RN License.
CCRC or CCRP required.
CITI training required within 90 days of hire.

Nice To Haves

Master of Science

Responsibilities

Act as a resource for investigators and support staff on pre-trial functions including budget development, contract negotiations and IRB applications.
Advise department study investigators and support staff on administrative and regulatory aspects of human subject research.
Develop and implement department policies, procedures and organizational tools to ensure compliance with MCW, state and federal standards.
Manage data systems supporting research activities.
Correspond with IRBs as needed.
Assist in the development and management of budget.
Recruit and train clinical research staff nurses and/or clinical research coordinators; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance.
Mentor and direct staff to achieve research goals.
Coordinates planning, feasibility, and implementation of new protocols with research nurses, investigators, and multidisciplinary study teams.
Maintains unit staffing needs by developing, implementing, and revising a staffing plan which assures efficient and effective delivery of participant care and facilitation of research studies during regular and after-hours clinical research visits.
Under physician direction, perform protocol-specific clinical tasks including patient assessment, screening, ordering tests, collecting specimens, and monitoring responses.
May administer medication or other types of protocol specific intervention.
Act as a liaison between Department Administrator and research staff.
Work closely with other departments and external agencies to advance the department’s research goals.
Develop, implement and monitor department research QI activities.
Implement and conduct quality control processes to ensure the highest data and research standards.
Develop clinical review data review plan and check specifications.
Utilize quality improvement tools & statistical process control to facilitate improvement of systems & processes.
Other duties as assigned.

Benefits

Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental.
Flexible Spending options
403B Retirement Package
Competitive Vacation and Paid Holidays offered
Tuition Reimbursement
Paid Parental Leave
Employee & Family Assistance Program (EFAP)
Pet Insurance
On campus Fitness Facility, offering onsite classes
Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.