Job Information
University of Michigan Clinical Research Coord Senior/Intermediate in Ann Arbor, Michigan
Clinical Research Coord Senior/Intermediate
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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 an experienced, positive, highly motivated, and organized Clinical Research Coordinator Senior or Clinical Research Coordinator Intermediate with excellent communication and multi-tasking skills to join our well-established research team: M-CHORD (Michigan Congenital Heart Outcomes Research and Discovery). M-CHORD consists of a dedicated team of study coordinators, project managers, database analysts, statisticians, a research program manager, and faculty leaders who all support the research endeavors of faculty, staff, and trainees in the congenital heart center. The congenital heart center is very productive in terms of research, with more than 150 publications per year.
The Clinical Research Coordinator (Senior or Intermediate) hired into this position will serve as a clinical research study coordinator for both single and multi-center, investigator-initiated and industry-sponsored studies and clinical trials (both FDA-regulated and non FDA-regulated).
A minimum of 2 full in-person days per week is required, though more in-person days may be required over time. 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 trials and studies to which the study coordinator is assigned.
Responsibilities*
Contribute to the development of process and tools within all 8 competency domains is expected
Scientific Concepts and Research Design
Ethical Participant Safety Considerations
Investigational Products Development and Regulation
Clinical Study Operations (GCPs)
Study and Site Management
Data Management and Informatics
Leadership and Professionalism
Communication and Teamwork
Essential*:
20% - Clinical Coordinator Responsibilities
Contributes to the development of processes and tools to support the non-GCP and GCP-related activities associated with study execution
Performs complex study procedures with accuracy
Develops processes and tools to address subject concerns efficiently
Capable of conducting all startup, active implementation, and closeout activities, including obtaining consent from patients and families.
20% - Data Coordinator Responsibilities
Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA)
Develops processes, tools, and training to capture data in accordance with ALCOA-C principles
Demonstrates the ability to create and manage databases
20% - Regulatory Coordinator Responsibilities
Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
Oversees regulatory documentation for quality assurance
Contributes to the development of processes and tools to enhance site compliance with the requirements necessary for the safe and effective development of investigational products
30% - Administrative Responsibilities
Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved
Runs regular study meetings
Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy; Develop standard operating procedures, work-aids and other guidance
10% - Training
- ex.: Provides mentorship of other clinical research staff; maintains certification
*Responsibilities will vary depending on unit specific needs. Some units/teams may have unique needs for proportionate focus on clinical, data, regulatory, or other needs. The CRC Senior position should take on all leadership responsibility except direct administrative supervision of staff.
Required Qualifications*
Bachelor'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 (https://acrpnet.org/certification/crc-certification/) ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA (https://www.socra.org/) ) 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 fromSoCRA (https://www.socra.org/) orACRP (https://acrpnet.org/certification/crc-certification/) prior to applying.)
Minimum 5 years (3 years for the intermediate position) of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA'sDefinition of a Clinical Research Professional (https://www.socra.org/certification/certification-program/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.
Desired Qualifications*
Experience serving as a study coordinator of multi-site clinical trials.
Experience serving as a study coordinator for FDA-regulated clinical trials.
Extensive experience with successful submissions to the IRB.
Familiarity with congenital heart disease.
Comfortable interacting with a pediatric population of varying acuity.
This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of difficulty.
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.
Job Detail
Job Opening ID
250069
Working Title
Clinical Research Coord Senior/Intermediate
Job Title
Clinical Research Coord Senior
Work Location
Ann Arbor Campus
Ann Arbor, MI
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Pediatrics-Cardiology
Posting Begin/End Date
6/07/2024 - 7/01/2024
Career Interest
Research
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