Clinical Research Coordinator Technician/Assistant- Term Limited

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.

Cover Letter Information:

• You must submit a cover letter as the first page of your resume to be considered for this position. Please use the cover letter to speak to how your experience fits with this position and why you should be considered.
• We also ask that you save your resume with your name in the file name and as a PDF.

Summary

The anesthesiology department is seeking a highly motivated and friendly individual to join the Michigan Perioperative Pain Research (MPR) team as a Clinical Research Coordinator. The MPR is a fast-paced, dynamic group that has several projects ranging from investigator initiated to sponsor funded (NIH, PCORI). Emphasis is placed on maintaining a positive work environment, fostering comradery, and encouraging professional development. Our mission is to better understand the transition to acute to chronic pain, perioperative outcomes, and post-operative pain management. This work will transform care, while dedication to our guiding principles enriches the lives of our team members and those in the community.

The CRC Technician position may independently provide study coordination for simple and moderately complex Clinical Research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant 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 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 include demonstrate, implement, execute, and use.

The CRC Assistant position is an entry level position that provides administrative and coordination support for multiple projects in the conduct of Clinical Research projects. This position may assist with study coordination but will not be assigned clinical trials independently. Demonstrates the ability to screen participants for study eligibility.

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.

Responsibilities*

Experience as part of a team with 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

Study Duties

• Complete aspects of clinical study coordination as assigned including: identifying and screening potential subjects, consenting and enrolling subjects, and coordinating participant study visits.
• Serve as a resource and train research staff in performing specified job duties as specified by the project and program managers.
• Assist in developing improved work flows and source documents as needed.
• Maintain source documents for accurate tracking, collection and recording of data.
• Perform data collection and entry into study databases.
• Perform recruitment activities at on and off-site UM locations.
• Utilizes critical thinking skills to recognize and solve patient/participant problems.
• Achieve proficiency in working with LabVantage, Qualtrics, and RKStudio.
• Be able to run reports, enter participant data into CRFs, abstract data from the EHR, distribute surveys in a timely manner and correctly.
• Keep study correspondences and documents organized.
• Ensure changes are implemented in study procedures and workflows as needed.
• Assist in preparation of reports for meetings and slide material for data presentations as specified by the project and program managers.
• Assist with adherence to project timeline and milestones.

Regulatory Duties

• Ability to identify and expeditiously report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the project and program managers and PI.
• Attain an in-depth understanding of the study/grant protocols and objectives to assist with their successful implementation.

General/Miscellaneous

• Staff members are expected to work independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
• Other tasks as defined.

Supervision Received: a Research Lead, Research Specialist Sr. and Faculty Principal Investigator.

Supervision Exercised: None.

Required Qualifications*

CRC 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 area 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.
• Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment.
• This position requires the highest levels of integrity, attention to detail, resourcefulness, and time management skills.
• Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative, and effective manner.
• Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem-solving.
• Ability to anticipate and plan for potential problems and formulate pragmatic solutions.
• Ability to remain calm in stressful situations.
• Eager to learn new skills and develop competencies within Clinical Research

CRC Assistant:

• High school diploma
• Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment.
• This position requires the highest levels of integrity, attention to detail, resourcefulness, and time management skills.
• Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative, and effective manner.
• Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem-solving.
• Ability to anticipate and plan for potential problems and formulate pragmatic solutions.
• Ability to remain calm in stressful situations.
• Eager to learn new skills and develop competencies within Clinical Research

Desired Qualifications*

CRC 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, and knowledge of university policies and procedures is desirable.

CRC 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, and knowledge of university policies and procedures is desirable.

Work Schedule

The work schedule for this position consists of M-F based on clinic and OR schedules, 40hrs.

Work Locations

The primary work location is University Hospital at Michigan Medicine, with some local travel and remote work.

Underfill Statement

This position may be underfilled at the CRC-Assistant title depending on the qualifications of the selected candidate.

Additional Information

Please note: This position is term-limited for 2 year with the possibility of renewal based on need and available funding. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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.