Clinical Research Coord Inter

Responsibilities

Collaborate closely with the PIs, Director of Operations & Director of Communications, program manager, and study team in planning and executing study activities

Organize and facilitate recurring nonfederal or federally funded study meetings (e.g., MPI, Steering Committee, Project PI). Ensure agendas are ready and minutes and next steps are distributed and documented

Closely collaborate with the onWHARD team and supervisors on logistics for the annual national study meetings and/or Open House events

Under close supervision from manager, serve as a key administrative contact for daily study operations, study tabling events, recruitment plans, and maintaining communication with team members, collaborators, and internal and external stakeholders

Participate in study start-up, active, and closeout phases; maintain inventory and coordinate related tasks as directed

Support study recruitment in the community and/or clinics as appropriate

Coordinate with researchers on additional onWHARD-affiliated projects, including fellowship-related research and other investigator-led studies, such as scheduling interviews and supporting related study logistics

Support creation and upkeep of study databases. Develop survey instruments and CRFs in REDCap and/or support staff working on REDCap

Complete case report forms (CRFs), track, identify and report AEs/SAEs in a timely manner, and in coordination with the rest of the study team, support with blood draw supply needs and making kits for distribution

Ensure accurate data entry and documentation through established processes and quality checks

Support scheduling of qualitative interviews and coordination with researchers, survey development, REDCap build, and assist with qualitative analysis using NVIVO, including for fellowship-related and other investigator-led research projects supported by onWHARD

Help train and support staff on data management; assist in resolving data discrepancies

With support from senior coordinator and/or manager, prepare and submit IRB applications, amendments, and continuing reviews

Draft consents; help develop and update protocols, SOPs, and study documents

Maintain regulatory documentation in compliance with guidelines, collaborating with study leadership

Monitor adherence to study protocols; identify and escalate issues in a timely manner

Stay current on regulatory requirements and participate in quality assurance activities

Under supervision/direction, coordinate communication among research teams, sponsors, and stakeholders

In close coordination with other CRCs and research assistants, proactively and independently manage project tasks in a timely fashion such as document filing, meeting scheduling, milestone tracking, and database management

Draft slides and minutes for meetings and send to team for review; track follow-up items. Support logistical needs for boards/committees, preparing presentations and reports as needed

Assist with financial and personnel documentation; monitor staff time and expenses under supervision

Support aspects app development, coordinating with the programming team

Perform additional administrative tasks as needed for the grants in close coordination with the program/admin coordinator

Reconcile expenses following University policies, ensuring reimbursement and payment for all applicable parties are completed in a timely manner. Coordinate with external vendors (e.g., PO, Contracts, MarketSite, QTO orders)

Under supervision, assist with Pilot Grant processes, including application management and accurate and timely award communications

Collaborate with Communications and Community Engagement teams to maintain a database of project materials

Support documentation, manuscript preparation, and compliance with NIH requirements

Help orient and support new research staff and students; other study-related tasks as assigned

Preferred

Community Engagement: Experience with community engagement or community-engaged research is desired

Master?s degree or progress toward a relevant graduate degree in a field such as Public Health, Social Work, Psychology, or a related discipline

Experience with University of Michigan systems, policies, and submission to IRBMed or IRB-HSBS

Demonstrated ability to manage multiple projects, set priorities, and meet deadlines accurately and efficiently; able to remain focused while multitasking

Experience orienting new research staff and demonstrated interpersonal skills to facilitate team cohesion and collaboration

Beginning involvement in clinical research committees at the University level, consistent with growth toward the CRC Senior title

Benefits

Hybrid work arrangement with at least 2–3 days per week onsite in Ann Arbor, MI, subject to hiring department discretion and annual review

Glassdoor

4.1

Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Michigan.

Ann Arbor, Michigan, USA

http://www.uofmhealth.org/

Late Stage

Leadership Team

Heather Ascani

Director, Business Strategy - Michigan Kidney Translational Research Core

Jack Kufahl

Chief Information Security Officer

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Qualifications

Education: Bachelor's degree in Public Health, Social Work, Psychology, Research Administration, Business, Education, Social Sciences, or a related field, or equivalent combination of education and experience

Experience: Minimum of 3 years of directly related experience (2 years for Assoc) in clinical or public health research coordination, including study management and regulatory compliance in an academic or health care setting

Research & Regulatory: Experience supporting study start-up, initiating IRB applications from scratch and related submissions, study management, and closeout phases, including familiarity with general IRB processes, eResearch, and regulatory documentation

Technical Skills: Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel) and experience with research database and data management software such as REDCap (building a database, managing and troubleshooting); familiarity with file-sharing, reference management, and communication platforms including Dropbox, Google Drive, Zotero, EndNote, etc

Communication & Organization: Ability to communicate actively; demonstrated attention to detail, follow-through on issues, and strong written and verbal communication skills. Able to independently prioritize tasks, organize work efficiently, and ensure high-quality outputs

Collaboration & Diversity: Demonstrated ability to work collaboratively with a wide variety of stakeholders from all walks of life and various organizations, including faculty, staff, participants, and community representatives in multidisciplinary and multicultural environments

Initiative & Independence: Demonstrated resourcefulness, problem-solving skills, and ability to work independently and collaboratively within established research protocols and supervisory direction

Experience using social media, reference management (e.g., EndNote, Zotero), project management (Trello), and virtual collaboration/presentation tools (Google Drive, Zoom, Teams, Slack, Canva)

Community Engagement: Experience with community engagement or community-engaged research is desired

Master?s degree or progress toward a relevant graduate degree in a field such as Public Health, Social Work, Psychology, or a related discipline

Experience with University of Michigan systems, policies, and submission to IRBMed or IRB-HSBS

Demonstrated ability to manage multiple projects, set priorities, and meet deadlines accurately and efficiently; able to remain focused while multitasking

Experience orienting new research staff and demonstrated interpersonal skills to facilitate team cohesion and collaboration

Beginning involvement in clinical research committees at the University level, consistent with growth toward the CRC Senior title

Experience: Minimum of 3 years of directly related experience (2 years for Assoc) in clinical or public health research coordination, including study management and regulatory compliance in an academic or health care setting.

Required skills

Clinical Research Coordination, Study Management, Regulatory Compliance, IRB Processes, eResearch, REDCap, Microsoft Office Suite, Community-Engaged Research, Google Drive, Zotero, EndNote, Trello

Experience

3+ years