Clinical Research Coordinator Oncology focus (Detroit, MI)

Profound Research•Detroit, MI

55d•Onsite

About The Position

The Clinical Research Coordinator manages clinical trial activities under supervision, ensuring compliance with applicable laws, regulations, study protocols, and procedures while upholding Profound Research’s mission, vision, and values. The role coordinates assigned trials from study start-up through participant visits, data collection, safety reporting, and monitoring follow-up. It also supports patient access to advanced therapies through community physician partnerships and helps maintain high ethical, scientific, and documentation standards. This position is performed on-site at a clinical or office facility in Detroit, Michigan. Daily commuting to site(s) is required, and travel between company sites, meetings, or partner locations may also be required. The position involves working with study participants, coworkers, leadership, sponsors, CROs, and vendors, as well as mentoring and training staff.

Requirements

One of the following education and experience combinations: bachelor’s degree and 2 years of relevant life science industry experience; associate’s degree and 4 years of relevant life science industry experience; or high school graduate and/or technical degree with at least 6 years of relevant life science industry experience, plus 1 year of Clinical Research Coordinator experience.
Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of starting the role.
Experience performing clinical assessments, including obtaining vital signs, conducting EKGs, drawing blood, and processing and shipping lab specimens.
Ability to work independently, plan, and prioritize with minimal guidance.
Strong attention to detail, organization, and communication with varied stakeholders.
Ability to work as part of a team and adapt to changing schedules and assignments.
Ability to communicate clearly verbally and in writing and to read and interpret detailed materials.
Ability to navigate a clinical facility, including areas with limited space, and transport supplies or work materials as needed.
Ability to commute daily to site(s).

Responsibilities

Conduct and manage clinical trial activities in accordance with research protocols and standards and all applicable laws, regulations, policies, and procedures.
Complete required company training, including ICH-GCP and IATA certification, in a timely manner.
Mentor and train staff in clinical trial conduct, protocol requirements, communication, and trial management.
Lead, implement, and coordinate assigned trial duties, including study start-up, vendor management, participant recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, adverse event and serious adverse event management and reporting, deviation management, monitoring visits, and follow-up.
Ensure good documentation practices are followed by team members when collecting, maintaining, and correcting study data and records, including source documents, case report forms, queries, drug dispensation records, and regulatory forms.
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
Collect and account for sponsor supplies, including lab kits, ancillary supplies, and investigational products.
Perform other duties as assigned.