Senior Clinical Research Coordinator

DM Clinical Research; Detroit (MI); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading research management organization in Detroit, MI, is looking for a Senior Clinical Research Coordinator. This role requires at least 5 years of experience managing clinical trials, particularly in a private setting. Responsibilities include ensuring adherence to FDA regulations, conducting patient visits, and maintaining regulatory documentation. The ideal candidate will be detail-oriented, energetic, and driven to meet quality goals within the dynamic environment of clinical research.

Qualifications

• Minimum of 5 years of experience as a Clinical Research Coordinator, preferably in industry-sponsored trials.
• Excellent knowledge of FDA regulations and GCP/ICH guidelines.
• Strong organizational and communication skills.

Responsibilities

• Complete required training including GCP and IATA.
• Maintain knowledge of current FDA regulations and study protocols.
• Conduct patient visits and document procedures in a timely manner.
• Resolve all issues from monitor letters promptly.

Skills

Detail-oriented

Multi-tasking

Energetic and goal-driven

Education

ACRP certification

Job description

Position

Senior Clinical Research Coordinator

Location

Detroit, MI

Job Id

739

# of Openings

1

Department

Clinical Operations - Detroit, MI

Employment Type

Full‑Time

Minimum Experience

Experienced

DM Clinical Research, the largest privately‑owned research management organization in the Houston area and one of the top 50 in the country, is looking for a Senior Clinical Research Coordinator experienced in coordinating studies for one of our research sites in Detroit, MI. This position works closely with our Clinical Research staff to provide excellent care to patients participating in our clinical trials.

Responsibilities

• Completing DMCR‑required training, including GCP and IATA.
• Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Adhering to their assigned protocols at their respective site(s).
• Maintain working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Collecting source and submitting source per Sponsor requirements via the Sponsor‑specified CRF system.
• Completing Sponsor‑required training prior to study‑start, to include, but not limited to:
  • Sponsor provided and IRB approved protocol
  • All amendments
  • Sponsor‑specified EDC and/or IVRS
• Continued recruitment and screening for their assigned protocols at their respective site(s) at all times as applicable
• Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s).
• Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s).
• Compiling and organizing all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable.
• Creating source documents for their assigned protocols at their respective site(s).
• Conducting patient visits, and all other protocol‑required procedures and documenting these in a timely manner.
• Reporting all Adverse and Serious Adverse Events to the appropriate authorities per Sponsor, IRB, and ICH Guidelines.
• Completing data entry and query resolution in a timely manner.
• Submitting required administrative paperwork per company timelines.
• Occasionally attending out‑of‑town Investigator Meetings.
• Ensuring data quality in all trials being conducted at their respective site(s).
• Addressing and resolving all issues from that monitor letters for all assigned protocols at their respective site(s) in a timely manner.
• Striving to meet Sponsor goals for their assigned protocols at their respective site(s).
• Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s).
• Any other matters as assigned by management.

Requirements

• Have at least three (5) years of experience as a CRC, preferably with practice coordinating industry sponsored trials in a private setting.
• Foreign Medical Graduate a plus.
• Be an energetic, go‑getter who is detail‑oriented and can multi‑task.
• Be goals‑driven while continuously maintaining quality.
• Have ACRP certification, which is a plus.