Position Summary: 

To facilitate and coordinate clinical trials using good clinical practice under the direction of the Investigators and Director. A CRC is responsible to ensure compliance with protocols and overall objectives, oversee subject recruitment, subject care, report adverse events and maintain required records of study activity. Works in a collaborative and cooperative relationship with other members of the research center’s team as well as study CROs and sponsors.

Minimum Qualifications:

Required

Bachelor’s DegreeAmerican Heart Association BLS (Within 30 days of Hire)Dangerous Goods Shipping certification (within 30 days of Hire)Good Clinical Practices/Human Subjects Research certifications (Within 7 days of Hire)Proficient with Microsoft Windows and WordPublic relations skills

Preferred

Certified Clinical Research Coordinator (CCRC)/Certified Clinical Research Professional(CCRP) (recertification every 2 or 3 yrs., respectively)Master’s DegreePhlebotomy CertificationPrevious Clinical Research Coordinator (CRC) experienceExperience with Excel, Powerpoint, and 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.

Study Start-up/Site ActivationSite Initiation VisitsTravel to investigator meetings and attend Investigator Meeting Webinars and Recruitment WebinarsIndependent protocol reviewPre-Screening activitiesChecking online recruitment sitesFollowing up with referralsMass emails, mailing letters (labels, stamping, stuffing envelopes)Taking patient calls from advertisementsScheduling patient/participant and study monitor visitsConducting and documenting study visitsInformed consent processIRB Submission and regulator and regular document managementPatient care/patient training/patient complianceProcedures (e.g., ECG, labs, vitals, height/weight, phlebotomy/venipuncture, spirometry)eDiary training, inventory, activation, and setupStudy drug training, dispensing, collecting and completion of accountability logsStudy drug and eDiary complianceAdverse event documentation, reporting and follow upSource document creation, editing, and managementQueriesStudy hand-off and cross-trainingData Entry / Electronic Data CaptureTemperature logsInteractive Web Response SystemsDangerous Goods/Biological Specimen lab shippingLaboratory procedures for collecting, processing, and shipping biological samplesCTMS and recruitment log updatesParticipant tracking and contact log managementStudy Closeout ActivitiesDocument Archiving and StorageMedical record review/reconciliationSupply ordering (medical and office)Answering phones, faxing/receiving medical records requestFaxing patient logs/patient log updatesWalk-ins (patients, FedEx)Other duties as assigned

Knowledge, Skills, and Abilities

Demonstrates sound judgement, patience, and maintains a professional demeanor at all timesAbility to adapt to change, manage uncertainty and possess exceptional time management skillsAbility to work in a busy and stressful environmentInvestigative Mindset – Strong ability to think criticallyStrong interpersonal, verbal and written communication skillsExercises tact, discretion, sensitivity and maintains confidentialityComputer applications, MS Office, EMR, internet applications and standard office equipmentDetail oriented, organizational skills and the ability to prioritize tasks and meet deadlinesStrong emotional intelligence, interpersonal and teamwork 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%).

The above statements are intended to describe the general nature and level of work being performed by people assigned to the job classification.  They are not to be construed as a contract of any type nor an exhaustive list of all job duties performed by individuals so classified.

77387225 Clinical Research Studies