Clinical Research Coordinator AssociateTechnicianAssistant

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Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job Summary

The Division of Geriatric & Palliative Medicine is seeking a full-time CRC to join a growing team of investigators working in the burgeoning field of palliative care that examines ways to improve access to therapies and strategies that improve quality of life. This person should be able to work independently. The first 6 months are provisory.

This 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 Clinical Research Technician position 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 can 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 most tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and can discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Social work or nursing background will be viewed favorably. Veteran Administration experience will also be viewed favorably.

Responsibilities*

Clinical Coordinator Responsibilities: Performs study procedures with minimal supervision. .

• Writing and executing scientific protocols
• Human subject identification, recruitment and data collection
• Coordination of study related visits
• Human subject monitoring; AE and SAE identification and tracking.
• Anticipate and mitigate the potential for protocol non-compliance.
• Triage simple subject concerns and issues appropriately

Data Coordinator Responsibilities

• Build and manage databases in Excel and REDCAP
• Track and report CONSORT data

Regulatory Coordinator Responsibilities

• Coordinate IRB applications through eResearch and ADVARA
• Maintain regulatory binder
• Track and report AE and SAE
• post studies in ClinicalTrials.gov and obtain the NCT.

Administrative Responsibilities

• Management of subject reimbursement and payments
• Assist with creating posters, abstracts, and articles
• Schedule, assist with preparation for, and attend study meetings, monitor visits, and audits.

Training

• All training requirements of previous level and up to date in all training assigned to this level.
• PEERRS, HIPAA, CITI GCP
• eRPM Regulatory training

Supervision Received: This position reports directly to Dr. Maria Silveira, Principal Investigator.

Supervision Exercised: None.

Required Qualifications*

Associate:

• 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.)

Technician:

• 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 SoCRAs 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.

Assistant:

• High school diploma or GED is necessary.

Desired Qualifications*

Associate:

• 4+ years of direct related experience.

Technician:

• Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable.
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Assistant:

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

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.

Underfill Statement

This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates qualifications.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

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 Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.