Clinical Research Coord Inter

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Job Summary

The Neurology Clinical Trials Organization (NeCTO) is seeking an experienced, positive, highly motivated, organized, and autonomous individual with excellent communication and multi-tasking skills to join our growing research team. This position will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of neurological clinical research studies. This position will provide study coordination for multiple clinical research studies of any complexity. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities. This position will report directly to a CRC-Lead (NECTO Project Manager) or the the NeCTO Manager.

Responsibilities*

BASIC FUNCTION AND RESPONSIBILITY

This position will provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from theClinical Research Coordinator Associateposition is required. Should begin to serve on various clinical research committees at the University level.

This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

CHARACTERISTIC DUTIES AND RESPONSIBILITIES

Expert level knowledge, skills, and abilities within all 8 competency domains is expected

1. Scientific Concepts and Research Design

2. Ethical Participant Safety Considerations

3. Investigational Products Development and Regulation

4. Clinical Study Operations (GCPs)

5. Study and Site Management

6. Data Management and Informatics

7. Leadership and Professionalism

8. Communication and Teamwork

Essential*:

30% - Clinical Coordinator Responsibilities

• Performs study procedures with accuracy

• Demonstrates ability to triage complex study concerns appropriately

• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits

• Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently

30% - Data Coordinator Responsibilities

• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles

• Demonstrates the ability to create CRFs, study documents, and tools

• Demonstrates ability to resolve complicated queries

30% - 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

• Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes

5% - Administrative Responsibilities

• Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines

• Provide other administrative support for study activity including management of subject reimbursement and payments

5% - Training

• Participates in trainings specifically for maintaining certification as a Clinical Research Professional

RELATED DUTIES

None

SUPERVISION RECEIVED

This position will report directly to a Clinical Research Coordinator Lead (NeCTO Project Manager) or the NeCTO Program Manager

SUPERVISION EXCERCISED

This position may provide functional supervision for student temporary employees.

Required Qualifications*

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.

• 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 )

• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

Desired Qualifications*

• Experience with Investigator-Initiated clinical trials.

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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .

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

253988

Working Title

Clinical Research Coord Inter

Job Title

Clinical Research Coord Inter

Work Location

Ann Arbor Campus

Ann Arbor, MI

Modes of Work

Hybrid

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Neurology Department

Posting Begin/End Date

11/05/2024 - 11/19/2024

Career Interest

Research

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