Clinical Research Coord Inter

Details

Posted: 12-Apr-24

Location: Ann Arbor, Michigan

Salary: Open

Categories:

Staff/Administrative

Internal Number: 247528

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.

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.
 

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.

• 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 or ACRP )
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Must be organized, efficient, self-motivated, and proficient in computer skills including Microsoft software applications.
• Ability to organize and manage multiple tasks/projects simultaneously, as well as prioritize and exercise good judgment.
• Ability to work independently with minimal supervision while maintaining effective collaborations and communication with a diverse team of individuals in a diplomatic, professional, collaborative, and effective manner.
• Candidate will be expected to prioritize multiple tasks, meet deadlines, and adhere to strict confidentiality policies.
• Must be comfortable working in the Emergency Department (following established protocols to facilitate social distancing and reduce COVID-19 transmission risks), interacting with diverse populations, and potentially discussing sensitive topics with study participants and families.

• Previous clinical research experience, clinic/hospital work or volunteer experience, and
  knowledge of the research protocols and processes are highly desired.
• The ideal candidate for this position will be able to work as a member of a collaborative
  team but have the ability to function independently with limited supervision after a
  period of on-boarding.
• Familiarity and experience with Epic, MiChart and eResearch applications. PEERS,
  regulatory compliance, IRB review and approval process, CITI or NIH Protection of
• Human Subjects Training Certification is preferred.
• Experience with REDCap (Research Electronic Data Capture), Qualtrics or a similar data
  capturing system and statistical methods background and responsibilities in previous
  employment is also preferable.

This position will assist with clinical trials within the Michigan Medicine Department of Emergency Medicine. While the primary work schedule will be Monday through Friday 8am-5pm, due to the nature of our patient care, this position will require flexibility and will routinely require covering evening and weekend shifts.

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.
 

The Department of Emergency Medicine at Michigan Medicine is committed to creating an
environment that is welcoming to all. We strive to value the unique contributions of individuals,
and support a culture of inclusivity among our employees, learners, and larger community. This
includes supporting the development of a diverse workforce across identities such as race,
ethnicity, national origin, sexual orientation, gender identity, age, citizenship, marital status,
religion, language, disability, and Veteran status. We are proud to be an equal opportunity and
an affirmative action employer. 

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.

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 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.

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

 

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About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
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