Clinical Research Coordinator Technician

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 University of Michigan Congenital Heart Center is seeking an experienced, positive, highly motivated, and organized Clinical Research Technician 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 Technician 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.

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*

Experience as part of a team with 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**:

25% Clinical Coordinator Responsibilities (ex.: Performs moderately complex study procedures with accuracy; Triages simple subject concerns and issues appropriately; Assesses studies for execution and troubleshoots potential implementation issues; Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.)

• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment

25% Data Coordinator Responsibilities (ex.: Completes simple to moderately complex data collection during study visits; Resolves simple data queries)

• May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.
• May obtain the CTN number for eResearch applications.
• Completes simple to moderately complex CRFs.
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials.

25% Regulatory Coordinator Responsibilities (ex.: Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

15% Administrative Responsibilities (ex.: Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)

• Demonstrates understanding of the clinical research objectives associated with the program.
• May communicate with study participants such as sending study correspondence via mail or email.
• May schedule subjects for research visits and FU appointments.
• May check study calendar for completion of study procedures.
• May manage study supply inventory.
• May utilize documents and systems to track recruitment and retention of participants.
• May complete and activate postings (advertisements, flyers, etc.) independently.
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)

10% Training (ex.: Participates in training opportunities on Good Clinical Practices (GCP))

• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understands the disease process per program.
• Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.

*Please refer to Clinical Research Career Ladder for specific description of each competency.

**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 Clinical Research Technician position will most likely support project implementation needs as part of a team.

Required Qualifications*

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 1 year 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.)

OR

• An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.

OR

• Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
• 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*

• 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 no be held to exclude other duties not mentioned that are of a similar kind or level of difficulty.

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/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

Job Opening ID

253468

Working Title

Clinical Research Coordinator Technician

Job Title

Clinical Research Technician

Work Location

Ann Arbor Campus

Ann Arbor, MI

Modes of Work

Hybrid

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Nonexempt

Organizational Group

Medical School

Department

MM Pediatrics-Cardiology

Posting Begin/End Date

8/23/2024 - 9/16/2024

Career Interest

Research