NHS Human Services, Inc.

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

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