Job Information
Bozeman Health Clinical Research Coordinator (FT- 1 fte) in Bozeman, Montana
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
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