Clinical Research Coordinator

Position Summary: 

The Clinical Research Coordinator (CRC) facilitates and coordinates multiple clinical trials in accordance with Good Clinical Practice (GCP) under the direction of investigators and the director. The CRC ensures adherence to research standards set forth by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), National Cancer Institute (NCI), and other regulatory agencies. Responsibilities include ensuring protocol compliance, recruiting and caring for study participants, documenting study activities, reporting adverse events, and maintaining effective collaboration with research teams, sponsors, and contract research organizations (CROs).

Minimum Qualifications:

Required

• Bachelor’s Degree.
• Current American Heart Association BLS, or ability to complete within thirty (30) days of hire.
• Current Dangerous Goods Shipping certification, or ability to complete within thirty (30) days of hire.
• Current Good Clinical Practices/Human Subjects Research certifications, or ability to complete within seven (7) days of hire.
• Intermediate proficiency with Microsoft Office products.

Preferred

• Master’s Degree involving a research component or thesis project.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
• Current Phlebotomy Certification.
• Previous Clinical Research Coordinator (CRC) experience.
• Prior experience with EPIC EMR.

Essential Job Functions:

In addition to the essential functions of the job listed below, employees must have on-time completion of all required education as assigned per DNV requirements, Bozeman Health policy, and other registry requirements.

• Ensure compliance with research protocols, regulatory requirements, and institutional policies while preparing and submitting necessary documentation to Institutional Review Boards (IRB), study Sponsors, and CROs.
• Oversee participant recruitment, screening, Informed Consent, enrollment, and  retention while maintaining effective communication and engagement with study participants, Sponsors, CROs, and department leadership.
• Coordinate study visits, monitor adherence to protocols, and collect and document study-related data, including adverse event reporting and resolution of data queries.
• Conduct and document clinical procedures such as ECGs, vital signs, spirometry, and biological specimen collection, processing, and shipping in accordance with study guidelines (Protocol, Lab manual, etc.) and Good Clinical Practice.
• Complete and maintain required regulatory documentation in the Investigator Site File and sponsor-provided/departmental vendor systems.
• Manage investigational product inventory, including training, dispensing, accountability, and compliance monitoring.
• Maintain data integrity through accurate entry into electronic data capture systems, tracking participant progress, and archiving essential study documents.
• Collaborate with investigators, nurses, and other healthcare professionals to optimize study execution and participate in site initiation visits, investigator meetings, and training sessions.
• Support operational and administrative activities, including inventory management, scheduling, correspondence, study progress reporting, and study closeout procedures.

Knowledge, Skills, and Abilities

• Demonstrates sound judgement, patience, and maintains a professional demeanor at all times.
• Exercises tact, discretion, sensitivity and maintains confidentiality.
• Performs essential job functions successfully in a busy and stressful environment.
• Learns current and new computer applications and office equipment utilized at Bozeman Health.
• Strong interpersonal, verbal, and written communication skills.
• Analyzes, organizes, and prioritizes work while meeting multiple deadlines.
• Investigative Mindset – Strong ability to think critically.
• Strong emotional intelligence, interpersonal, teamwork, and public relations skills.

Schedule Requirements

• This role requires regular and sustained attendance.
• The position may necessitate working beyond a standard 40-hour workweek, including weekends and after-hours shifts.
• On-call work may be required to respond promptly to organizational, patient, or employee needs.

Physical Requirements

• Lifting (Rarely – 30 pounds): Exerting force occasionally and/or using a negligible amount of force to lift, carry, push, pull, or otherwise move objects or people.
• Sit (Continuously): Maintaining a sitting posture for extended periods may include adjusting body position to prevent discomfort or strain.
• Stand (Occasionally): Maintaining a standing posture for extended periods may include adjusting body position to prevent discomfort or strain.
• Walk (Occasionally): Walking and moving around within the work area requires good balance and coordination.
• Climb (Rarely): Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like using feet and legs; may also use hands and arms.
• Twist/Bend/Stoop/Kneel (Occasionally): Twisting, bending, stooping, and kneeling require flexibility and a wide range of motion in the spine and joints.
• Reach Above Shoulder Level (Occasionally): Lifting, carrying, pushing, or pulling objects as necessary above the shoulder, requiring strength and stability.
• Push/Pull (Occasionally): Using the upper extremities to press or exert force against something with steady force to thrust forward, downward, or outward.
• Fine-Finger Movements (Continuously): Picking, pinching, typing, or otherwise working primarily with fingers rather than using the whole hand as in handling.
• Vision (Continuously): Close visual acuity to prepare and analyze data and figures and to read computer screens, printed materials, and handwritten materials.
• Cognitive Skills (Continuously): Learn new tasks, remember processes, maintain focus, complete tasks independently, and make timely decisions in the context of a workflow.
• Exposures (Rarely): Bloodborne pathogens, such as blood, bodily fluids, or tissues. Radiation in settings where medical imaging procedures are performed. Various chemicals and medications are used in healthcare settings. Job tasks may involve handling cleaning products, disinfectants, and other substances. Infectious diseases due to contact with patients in areas that may have contagious illnesses.

*Frequency Key:  Continuously (100% - 67% of the time), Repeatedly (66% - 33% of the time), Occasionally (32% - 4% of the time), Rarely (3% - 1% of the time), Never (0%).

77387225 Clinical Research Studies