Clinical Research Coord Senior/Intermediate

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