Clinical Research Coord Inter

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.

Summary

Highly motivated individual sought for a full-time clinical research coordinator healthcare position within the Department of Emergency Medicine Division of Critical Care at Michigan Medicine. The candidate will serve as a clinical research coordinator for multiple studies (including clinical trials and human subject?s studies), will work closely with Division of Critical Care leadership and faculty, and will support a robust and growing clinical and human studies research program.

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. 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.

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.

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

Responsibilities*

Characteristic Duties and Responsibilities

Expert level knowledge, skills, and abilities within 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

• Responsible for all aspects of research regulatory compliance, such as preparation/writing of

IRB protocols for submission and maintenance (including the initial applications, amendments,

scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.),

while ensuring effective routine communication with the IRB.

• Create and maintain study standard operating procedures/protocols and research binders.

• Perform literature reviews.

• Completion of study tracking documentation accurately and in a timely manner.

• Create and routinely update project tracking systems.

• Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements.

• Responsible for all aspects of research study coordination: Identifying/pre-screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects,

consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting follow-up assessments.

• Coordination of specimen collection and storage. Monitor subjects for safety and compliance with protocols. Coordination/management of all daily study operations.

• Effectively update study sponsors on annual progress of research projects. Will be responsible for working with various groups to execute legal contracts (where appropriate). May reconcile study expenses, communicate/negotiate with study sponsor, the IRB, investigational pharmacy, referring doctors, CTSUs, and additional units (such as the Michigan Clinical Research Unit (MCRU) team).

• This position will also assist with coordination of research meetings, additional research initiatives, and collaborating within Emergency Medicine and across Michigan Medicine.

• May act as liaison with other departments, divisions, and organizations.

• Responsibility for the management/maintenance of large, secured research databases to include all subject data, records, and documentation, data entry/extraction, and routinely

perform data-quality checks. Work closely with data analyst(s) to ensure data integrity and alignment with study protocols. Work with faculty and staff to efficiently manage multiple data capturing systems.

• Create and organize data into easily manageable spreadsheets, tables, and graphs for periodic presentations to study staff and investigators, and for regulatory bodies including the NIH and IRBMED. May assist with data analyses/interpretation of results, in addition to preparing project reports or publications, and presenting updates as appropriate.

• May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluates results.

• Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions. Consults with study staff to refine or adapt methodologies to fit research goals and specific aims.

• Collaborates in development of new techniques and procedures/protocols.

• Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational

problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality. Regular active participation in research meetings will be expected.

• Diversity, equity, and inclusion ongoing education will be required, and demonstration of cultural awareness and humility will be always expected when interacting with faculty, study

staff, research participants and families, from diverse backgrounds.

• This position will assist with clinical trials within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will routinely require

covering some evening and weekend shifts.

• Cross training with other staff will be required.

• Additional work-related tasks, not specifically outlined above, will be required of the candidate.

Supervision Received

This position reports directly to Administrator and Manager for the Department of Emergency

Medicine's Division of Critical Care.

Supervision Exercised

Could provide functional supervision (likely in limited capacity such as training) of staff in titles

within the CRC Career Ladder and learners.

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