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.
Summary
The University of Michigan Congenital Heart Center is seeking a Clinical Research Project Manager to serve as project manager and study coordinator for a pediatric, multi-center, investigator-initiated, FDA-regulated device clinical trial led by the University of Michigan. The device is patient-specific and the IDE is held by a University of Michigan investigator.
This position may provide study coordination and/or project management for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from Clinical Research Coordinator - Senior and/or CRC Lead is required. This position has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.
Mission Statement
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Responsibilities*
The selected candidate will have both Project Management and Study Coordinator duties. These specific duties include:
Project Management.
The selected candidate will:
- Serve as primary contact for sites participating in the multi-center clinical trial. Along with the UM team, the selected candidate will guide each site through study start up, enrollment, follow-up, and close out, and answer any questions that arise.
- Write clinical trial documentation as needed.
- Work with the device manufacturer to ensure the patient-specific devices are manufactured, sterilized, and delivered on time to both UM and participating sites.
- Coordinator monitoring visits for participating sites.
- Work with the SABER team at UM to ensure the trial database is designed and operates per specifications.
- Work with MICHR IND/IDE Investigator Assistance Program (MIAP) to ensure compliance with all applicable FDA regulations and reporting
- Work with liaison to create and update clinicaltrials.gov registration.
- Along with finance team, monitor the clinical trial budget.
- Maintain regulatory binder.
- Maintain IRB application.
- Support Expanded Access use of the device under the IDE for children who are ineligible for the trial
Study Coordination.
As UM is a participating site in the clinical trial, the selected candidate will:
- Ensure that subjects are consented, the protocol adhered to, and all regulatory documents are in order.
- Participate in all monitoring visits.
- Ensure data are entered, and queries answered, in a timely manner.
- Work within CTSU framework for initiating and carrying out the clinical triall, including enrolling and tracking patients in OnCore.
- Process patient incentive reimbursements.
The selected candidate will be embedded in the congenital heart center research team (M-CHORD), which consists of a dedicated team of study coordinators, project managers, and an analytic team, and faculty leaders.
The selected candidate may work from home on days where in-person work is not required, as agreed upon with the selected candidate's manager and the PI of the trial.
After the initial start-up phase of the clinical trial, additional clinical trials and studies may become the responsibility of the selected candidate.
General responsibilities for this clinical trial, and future clinical trials and studies, are listed below.
Clinical Coordinator Responsibilities
- Demonstrates the ability to create and manage the logistics for a new clinical trial.
- Applies critical thinking and creative problem-solving skills in the development of new processes, procedures, tools, and training to enhance clinical research activities.
- Demonstrates the ability to evaluate a monitoring plan against protocol and relates the plan to study team members.
- Manage workloads and resources/procurement.
- Using available resources at the University, determines study site feasibility.
- Provides input on feasibility of new studies (workflow, resources, populations). Advises PI or clinical research teams of inconsistencies, errors or any issues of concern that may result in non-compliance or logistic issues.
- Assesses study budget for staff resource assessment.
- Proficient in study implementation.
- Knowledge of risk management strategies and principles.
- Responsible for workflow process and study planning.
- Develops tools and trainings to aid in the creation of study budgets and tracking of invoiceable items.
- May manage the research conduct at other sites if U of M is acting as a coordinating center for a multi-site study.
- Provide appropriate financial oversight
- Proficiency in budget and resource management
- Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
- Demonstrated expert knowledge of clinical research systems.
- Assist in writing and review of protocols.
Data Coordinator Responsibilities
- Develops or contributes to the development of processes, tools, and trainings to ensure the accurate collection of data at the site level.
- Performs at the highest level of data management, including the monitoring of data collection and reporting to ensure compliance.
- Oversees study conduct by staff and ensures quality work is done.
- Reviews manuscripts/poster presentations/abstracts as appropriate.
- Proficient in data management and results reporting.
- Demonstrates ability to create and manage the logistics for a new clinical research trial.
- Responsible for implementing study assessment needs.
- Knowledge of the roles and responsibility of the various stakeholders in clinical research.
- Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency.
Regulatory Coordinator Responsibilities
- Performs internal audits and adjusts SOPs for the management of IPs according to FDA regulations and GCPs.
- Knowledge of fraud and misconduct identification, reporting, and management.
- Responsible for workflow process and study planning.
- Facilitates internal and external audits.
- Ensure study compliance Provides oversight and follows FDA- Good Clinical Practices (GCP) or OHRP guidance for clinical research.
- Ensures ethical guidelines are reflected in SOPs by adapting any established procedures, processes, or workflows to reflect any new or updated regulations.
- Designs processes, tools, and trainings to guide study team members in the understanding, recognition, and documentation of subject protection and safety issues.
- Proficient in regulatory and compliance matters.
Administrative Responsibilities
- May run/delegate staff meetings
- May provide administrative supervision of a team > 2 employees
- May manage HR activities
- Knowledge of management concepts of and effective training methods to manage risk and improve quality in conduct of a clinical research study.
- Recruit and train appropriate personnel for clinical research
- Utilize staff performance metrics
- Knowledge of the principles and practices of leadership, management, and mentorship, and how to apply them within the working environment
Training
- All training requirements of the previous level.
- Specialty training or expertise is achieved at this level.
- Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
- Attends and participates in all training assigned to this level.
Required Qualifications*
Clinical Resource Project Manager:
- CRC Governance Committee review and approval
- Master's Degree in Health Science or an equivalent combination of related education and experience is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
- Minimum 6 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)
- Excellent interpersonal, oral, and written communication skills Demonstrated knowledge of medical and research terminology. Ability to work with minimal supervision with diverse teams of people in a diplomatic, collaborative, and effective manner
- Exceptional organizational and computer skills are required with proficiency in Microsoft software applications
- Demonstrated problem solving and conflict resolution skills. Ability to multi-task, work well under time constraints and meet deadlines.
Clinical Research Coordinator Senior and Lead Required Qualifications:
- CRC Governance Committee review and approval
- Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
- Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
Desired Qualifications*
- Previous experience with coordination and management of device trials (IDE)
- Experience leading a multi-site clinical trial
- Demonstrated understanding of FDA regulations
- Extensive experience with successful submissions to IRB
- Familiarity with congenital heart disease
Work Schedule
In this position you'll typically work Monday through Friday. Occasional weekend work may be required.
Work Locations
The in-person portion of this role will be at Mott Children's Hospital. The selected candidate may work from home on days where in-person work is not required, as agreed upon with the selected candidate's manager and the PI of the trial.
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Background Screening
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. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening 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.