Clinical Research Coord Inter

Summary

The University of Michigan's Department of Physical Medicine and Rehabilitation (PMR) and the Center for Disability Health and Wellness (CDHW) are looking for professional, experienced and enthusiastic applicants who are interested in participating as part of a dynamic, fast-paced, and well-established disability health research team. This position will coordinate, supervise and conduct research activities to support the federally funded Michigan Spinal Cord Injury Model Systems (MI-SCIMS) and other federal Center grants.

The overarching focus of MI-SCIMS is to enhance the health, well-being, participation and quality of life of individuals living with Spinal Cord Injury (SCI). The individual in this position will work under the supervision of the Project Director (Michelle Meade) to ensure the coordination and completion of all project activities as required by our funder and in coordination with the National SCI Database Center and other SCI Model System Centers throughout the United States. They will develop, submit and revise applications to the University of Michigan, or other, Institutional Review Boards (IRBs) and ensure both the implementation of human subjects protections and the highest ethical standards. They will ensure the training and accuracy of all individuals interviewing participants and entering information into databases and may be called upon to represent the MI-SCIMS on virtual or national meetings with collaborators as well as to work in partnership with or train research staff at Mary Free Bed Rehabilitation Hospital, who serves as our partner in the MI-SCIMS. The individual in this position will also personally engage with potential and existing research participants, including regularly (multiple times each week) going to the Michigan Medicine inpatient rehabilitation unit to meet with individuals with new SCI, explain the research study, conduct informed consent processes and complete in person and telephone (or zoom) based interviews, extract information from the medical record and enter database into REDCap and other electronic databases. This position can perform the majority of tasks independently and perform quality checks of their work. The person in this position will have office space at the Burlington Building but will be expected to regularly travel to Michigan Medicine's University Hospital or Chelsea Hospital to complete job responsibilities. Applicants with an understanding of SCI or other disability issues, as well as issues of diversity, equity and inclusion, and survey/social focus research will be strongly considered for this position.

The individual in this position will demonstrate advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This person will apply critical thinking and creative problem-solving skills across a wide variety of clinical studies. This person will contribute 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 Clinical Research Coordinator track continues to build on the person?s 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.

Responsibilities*

Responsibilities will include but not limited to activities such as managing the recruitment and retention of potential patients for participation in the SCIMS project, conducting interviews with them and obtaining needed documentation from their medical records, conducting data management, data quality checks and data extraction, conducting interviews of long-term SCIMS participants over the phone, and assisting in the coordination of the day-to-day activities of a research assistant who will also be involved in the interview process for this study. Essential skills include the ability to multitask, remain organized and clear, concise communication skills. Supporting IRB activities and overseeing adherence of study protocols. This role requires oversight of human subject recruitment as well as mentorship of research assistants. Adhering to study protocols and follow-up communication are critical responsibilities of this position as well as respecting the confidentiality of our research participants. The successful candidate must be flexible and willing to assist with other project activities as assigned.

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

Additional Duties and Responsibilities

* Managing and implementing activities associated with recruitment and retention of participants
* Manage human subjects protections for multiple projects, including the submission and revisions of IRB applications, amendments and ORIOs
* Development and submission of Data Use agreements
* In-person and remote collection of data from research participants
* Act as an extension of SCI Clinical team and program, ensuring the integration of research activities as part of the U-M continuum of care and spending time in hospital and clinic environments
* Develop and Implement strategies to track, engage and collect self-report data from participants using multiple formats, including but not limited to phone, email, mail, texting, and in person
* Review and extract information / data from medical records
* Development, management and associated quality control checks of data management systems, including as associated with REDCap and other platforms
* Develop and implement standardized research protocols and manuals of operations (MOPs)
* Provide supervision, direction and guidance to research assistants and students as applicable
* Assist with grant-related paperwork
* Other research activities as requested by Project Director or CDHW Manager

Supervision Received:

This position reports directly to Michelle Meade, PhD., Professor, Department of Physical Medicine and Rehabilitation and Director, U-M Center for Disability Health and Wellness

Supervision Exercised:

This position will provide administrative and functional supervision of staff at the Associate, Technician and Assistant levels within the CRC Career Ladder.

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