Clinical Research Coord Assoc

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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.

Job Summary

The REMEDY team at the University of Michigan UM manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM industries and Universities. We specialize in multi-center including international device trials as well as outcomes research drug trials and investigator-initiated studies. As we continue to expand our portfolio we are looking for detail orientated highly motivated compassionate individuals to join our team.

Clinical Research Coordinator (CRC) Position

This clinical research coordinator CRC position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently consistently and accurately and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies navigate available resources appropriately effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.

Key Behavioral Competency Descriptors

• Demonstrate
• Implement
• Execute
• Use

Responsibilities

Characteristic Duties and Responsibilities

Independent knowledge skills and abilities 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

Responsibilities will include but are not limited to:

• Understanding of protocol elements and requirements
• Executing study procedures
• Anticipating and mitigating the potential for protocol non-compliance
• Accurate implementation of protocol procedures
• Describing and performing routine study management activities
• Performing study procedures with minimal supervision
• Triaging routine participant concerns and issues appropriately
• Scheduling assisting with preparation and attending study-related meetings e.g. study initiation meetings audits monitoring visits or community-based organizational meetings
• Participating in regular study meetings
• Properly completing payment forms and pays participants accordingly
• Serving as primary point of contact for study and/or a study team
• Documenting data in accordance with ALCOA-C principles and/or the study data management plan
• Completing complex data collection during study visits
• Resolving data queries
• Appropriately identifying and reporting adverse events AEs Serious Adverse Events SAEs and Other Reportable Information and Occurrences ORIOs
• Maintaining essential documents as outlined in the GCP guidelines or other relevant guidelines
• Other related duties as assigned

Supervision Received

This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery.

Supervision Exercised

None

Required Qualifications

• Bachelors 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 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.
• Desired Qualifications:
• 4 years of direct related experience
• An understanding of medical terminology
• Experience in a large complex health care setting
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of university policies and procedures is desirable

Work Schedule

• Hours: 40 hours
• Shift: Hours
• Days: Days
• Occasional evening and weekends on call

Modes of Work

Positions that are eligible for hybrid or mobile remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time and for any reason throughout the course of employment. Learn more about the work modes.

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 Statement

The University of Michigan is an equal employment opportunity employer.