Clinical Research Coordinator - Assistant (Term Limited)

Michigan Medicine; Ann Arbor (MI); On-site; USD 32,000 - 42,000; Full time

Job summary

Michigan Medicine is seeking an entry level Administrative Research Coordinator to support multiple clinical research projects. The role provides administrative and coordination support, helps with study coordination tasks, and may assist with registries and data collection.

You will work under supervision, maintain study records, communicate with participants, and perform clerical duties while adhering to HIPAA and U-M policies.

Qualifications

• High school diploma or GED required; associate degree desirable.
• Minimum 1 year of related clinical research experience recommended.
• Understanding of medical terminology is desirable.
• Experience in a large health care setting is a plus.
• Strong communication with staff at all levels is essential.
• Knowledge of university policies is helpful.
• Experience with spirometry or sputum induction is a plus, on-site training available.
• Clinical experience with respiratory patients is desirable.

Responsibilities

• Performs clerical duties including mailing, filing and patient contact.
• Assists with study procedures and basic data collection during visits.
• Triages simple subject concerns and supports study initiation activities.
• Maintains regulatory documents and supports audits.
• Communicates with study participants via mail or email as needed.
• Supports recruitment activities and coordination of study visits.
• Ensures confidentiality and HIPAA compliance in all tasks.

Skills

Administrative support

Attention to detail

HIPAA knowledge

Education

High school diploma or GED

Associate Degree in Health Science

Tools

Microsoft Office

EMR systems

Job description

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

This is the entry level position on the Michigan Medicine CRC Career Ladder. This position 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. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.

Characteristic Duties And Responsibilities

Knowledge of 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*

• Performs simple study procedures with accuracy.
• Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records.
• 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
• May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV
• May assist in and attends monitor visits and or audits.
• Ability to assist with regulatory aspect of clinical trial management.
• Prepare study procedure kits, shippers, CRFs, and requisition forms.
• Ability to work independently or as a member of a team
• Exceptional organizational and computer skills in Microsoft software applications.
• Ability to work with minimal supervision while maintaining productivity standards
• Demonstrated problem solving and conflict resolution skills.
• Ability to multi-task, work well under time constraints and meet deadlines.
• Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
• Perform other related duties as assigned.
• Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
• Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
• 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.

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.

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.)

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.

Other duties as assigned

Required Qualifications*

High school diploma or GED is necessary.

Desired Qualifications*

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.
• An understanding of medical terminology
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary
• 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.
• Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available.
• Clinical experience with respiratory patients is highly desired.

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?