Clinical Research Coordinator (FT- 1 fte)

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 Degree
• American 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 Word
• Public relations skills

Preferred

• Certified Clinical Research Coordinator (CCRC) / Certified Clinical Research Professional(CCRP) (recertification every 2 or 3 yrs., respectively)
• Master’s Degree
• Phlebotomy Certification
• Previous Clinical Research Coordinator (CRC) experience
• Experience 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 Activation
• Site Initiation Visits
• Travel to investigator meetings and attend Investigator Meeting Webinars and Recruitment Webinars
• Independent protocol review
• Pre-Screening activities
• Checking online recruitment sites
• Following up with referrals
• Mass emails, mailing letters (labels, stamping, stuffing envelopes)
• Taking patient calls from advertisements
• Scheduling patient / participant and study monitor visits
• Conducting and documenting study visits
• Informed consent process
• IRB Submission and regulator and regular document management
• Patient care / patient training / patient compliance
• Procedures (e.g., ECG, labs, vitals, height / weight, phlebotomy / venipuncture, spirometry)
• eDiary training, inventory, activation, and setup
• Study drug training, dispensing, collecting and completion of accountability logs
• Study drug and eDiary compliance
• Adverse event documentation, reporting and follow up
• Source document creation, editing, and management
• Queries
• Study hand-off and cross-training
• Data Entry / Electronic Data Capture
• Temperature logs
• Interactive Web Response Systems
• Dangerous Goods / Biological Specimen lab shipping
• Laboratory procedures for collecting, processing, and shipping biological samples
• CTMS and recruitment log updates
• Participant tracking and contact log management
• Study Closeout Activities
• Document Archiving and Storage
• Medical record review / reconciliation
• Supply ordering (medical and office)
• Answering phones, faxing / receiving medical records request
• Faxing patient logs / patient log updates
• Walk-ins (patients, FedEx)
• Other duties as assigned

Knowledge, Skills, and Abilities

• Demonstrates sound judgement, patience, and maintains a professional demeanor at all times
• Ability to adapt to change, manage uncertainty and possess exceptional time management skills
• Ability to work in a busy and stressful environment
• Investigative Mindset Strong ability to think critically
• Strong interpersonal, verbal and written communication skills
• Exercises tact, discretion, sensitivity and maintains confidentiality
• Computer applications, MS Office, EMR, internet applications and standard office equipment
• Detail oriented, organizational skills and the ability to prioritize tasks and meet deadlines
• Strong emotional intelligence, interpersonal and teamwork skills

Physical Requirements

• Lifting, Pushing, and Pulling : Lift 30 pounds of weight (pick up supplies, move equipment, etc.) Carry equipment / supplies.
• Extended Hours : The role may involve working for extended periods, requiring sitting, walking, or standing for eight or more hours daily.
• Flexible Schedule : The position may necessitate working beyond a standard 40-hour workweek, including weekends and after-hours shifts
• On-Call Availability : On-call work may be required to respond promptly to organizational, patient, or employee needs
• Effective Communication : Proficient in effective communication, both in person and through various technologies
• Handling Challenging Situations : The role may involve dealing with upset individuals, requiring the ability to de-escalate situations and work effectively with frustrated patients, families, or employees
• Repetitive Tasks : Ability to perform repetitive tasks as needed to fulfill job responsibilities

Exposures

Tasks Include Potential Exposure : Job tasks may involve exposure to :

• Bloodborne pathogens, such as blood, bodily fluids, or tissues.
• Radiation in settings where medical imaging procedures are performed
• Various chemicals and medications 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

77387225 Clinical Research Studies