How to Apply
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
This role will serve as the Clinical Research Project Manager in the Oncology CTSU - Clinic Research Group (CRG) in support of the Cancer Center Clinical Research Teams (CRT).
Project management (25%)
Attends CRT meetings on an as needed basis in order to provide support to CRG staff and reinforce CRG roles, policies and procedures. Works with CRTs, CRG-QI group and CRG Manager to develop and promote standard process within and across CRTs; drafting new SPGs as needed and assisting with implementation of formal quality improvement plans. Problem solves with clinical and project teams to address high-level process issues that arise and impact the conduct of trials. Represent CRG staff in Cancer Center clinic work groups, research work groups and other committees as assigned by the manager.
Involved in the training of new staff in collaboration with the Administrative Manager. Meets regularly with new hires to track and assesses onboarding progress. Serves as a resource for the group, providing guidance regarding internal policies and procedure as well as FDA, ICH, GCP and HIPAA regulations. Provides feedback on design/creation of study specific documents and assists in training personnel to develop them.
Assists Administrative Manager to review feasibility, budgets and follow up on issues. Reviews/assesses progress of team in relation to ongoing workload and assists in making determination regarding workload rebalancing and new staff justifications. Assists manager to review resumes and schedule interviews for open positions. Assists manager with completion of annual review evaluations and mid-year reviews. Assist manager in troubleshooting various concerns and issues raised by programs and clinical staff. Assists manager with the development and implementation of performance plans as needed to address specific personnel issues. Provide supervision to the group in the absence of the Manager. Work with the manager on special projects as needed.
Will have Functional Supervision responsibilities. May have Administrative supervisory role in the future.
Experimental Therapeutics Project Manager (25 - 50%)
Work with Coordinators and Physicians across disease groups to implement Experimental Therapeutic studies.
Ensuring appropriate trainings by investigators and staff. Assist study coordinators with screening, enrollments and any other needed tasks. Provide primary study coordinator support for Experimental Therapeutic studies in some situations. Share updates related to the studies including amendments, administrative letters with all participating study coordinators. Responsible for making sure that all study activities are following protocol guidelines. Work closely with Data Management and Regulatory Coordinators to implement Experimental Therapeutic studies.
Float Coordinator (25 - 50%)
Provide or arrange coverage for absences, medical leave, transitions, or assist CRG staff with high volume workload on a particular day. Provide primary study coordinator support for some studies in CRTs where the workload has increased until additional staff are justified.
Study Coordinator responsibilities
Assists with Identifying, screening, consenting and enrolling subjects. Coordinates or facilitates correct timing of study visits and procedures with patients and clinic staff. Communicates with nurses, IDS, physicians, NP’s/PA’s, phlebotomists and other research staff to correct/prevent protocol errors. Under direction of MD – create orders for study specific lab work and diagnostic procedures. Follows up for abnormal or unexpected findings. May perform ECG or other procedures as needed. Works with research lab services and staff to maintain lab supplies. Creates source documents for accurate tracking, collection, and recording of experimental data. Follows through on patient complaints or questions including billing issues. Expeditiously routes AE and SAE information between staff, PI, and oversight agencies as appropriate. Serves as a resource and contact person for active protocols.
Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations. and maintains knowledge of current ICH and CFR guidelines. Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
Bachelor's Degree in health science or health related field.
At least three years of experience as a Clinical Research Coordinator.
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
Excellent computer skills including proficiency in Microsoft software applications.
Excellent organizational skills including the ability to multi-task and work well under time constraints and deadlines.
Willingness to be flexible and accept continuous change in a dynamic working environment.
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner that fosters team building.
Demonstrated customer service & conflict management skills
Demonstrated ability to collaborate in a manner that fosters team building and provides direction for team members
Demonstrated ability to work effectively with administrators, physicians, peers and staff of all disciplines to enhance and improve the Research patient experience
Demonstrated Project Management and relationship building skills
Ability to work collaboratively with Leadership to promote an open honest working environment
SOCRA or ACRP certification (or willing to acquire certification in one year)
Master’s Degree in health science or health related field or PMP
Previous experience with MiChart (Epic EMR), oncology, clinical trials
Understanding of Lean techniques
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.