Clinical Research Coordinator
The Clinical Research Coordinator (CRC) provides research coordination and support to the principal investigators, patients, and Gundersen Health System staff for projects that support the mission and objectives of Gundersen Medical Foundation. The CRC meets the expectations of a professional employee.
Collaborates with investigators to recruit eligible subjects to clinical protocols.
Facilitates and oversees research studies by preparing regulatory documents for submission to the Institutional Review Board (IRB), managing data collection and developing and maintaining databases for the submission of protocol forms and treatment information to the Institutional Review Board. Identifies strategies to prevent protocol violations and is responsible for adverse event management and study closeout.
Responsible for overall coordination of research studies, including but not limited to, contracts, budgets, billing, monitoring, audits, mailing, lab kits, and submission of patient information.
Monitors treatment implemented by Physician or RN-CRC for protocol compliance and occurrence of adverse events. Identifies and implements strategies to prevent protocol violations.
Obtains and maintains certification, via testing for:
Participates in the contract research organization's investigator meeting to become knowledgeable about the scientific, medical, and administrative aspects of the protocol, and attends meetings with specified research groups or sponsors. Some travel required.
Teams with the RN-CRC to facilitate the scheduling of tests and procedures for subjects participating in clinical trials according to protocol design, as well as facilitate/perform patient and family understanding of the protocol and informed consent as determined by scope of study.
Facilitates the collection, processing, and submission of specimens (e.g. blood/serum, pathology slides) to the appropriate location per protocol requirements.
Responsible for ordering and disposal of investigational drugs and maintaining accurate drug accountability logs per protocol specifications.
Conducts each clinical trial using knowledge of research guidelines and regulations in accordance with the Code of Federal Regulations, Good Clinical Practice, Gundersen Lutheran Institutional Review Board, HIPAA, and Gundersen Lutheran policies and procedures. Maintains up-to-date knowledge of clinical research as it relates to medical practices and Federal Regulations.
Performs other job related responsibilities as requested.
|Scope of the Job|
|Age Specific Population Served||Pediatric (1 - 12 years)|
Adult (18 - 64 years)
Geriatric (65 years & older)
Infant (less than 1 year)
|OSHA Category||Category I - All Employees in this job title have a reasonably anticipated risk of occupational exposure to blood and/or other potentially infectious materials.|
|Education and Experience:|
|Required||Associate degree in Clinical Research Coordination or a related field |
|Desired||Bachelor's degree in a health related field |
|Required||2 years of experience in a health care setting.|
|Desired||2 years of experience in a health care setting with research experience.|
|Computer Systems/Software/Applications||use Microsoft Office Products, Adobe and other similar applications|
|Communication||excellent oral and written communication skills|
|Communication||communicate with ease on a professional level|
|General - All Positions||have professional attitude in regard to motivation, cooperation, flexibility, confidentiality, ethics and personal development|
|General - All Positions||work cooperatively with a wide variety of people|
|General - All Positions||use listening skills to identify important information in oral communication|
|Leadership||problem solve - evaluate, analyze, negotiate and recommend alternatives|
|Leadership||use effective time management|
|Leadership||work independently: self-disciplined|
|Leadership||plan, organize, execute assignments to meet deadlines|
|License and Certifications|
|Required||Valid Driver's License (DL) |
|Desired||Current American Heart Association (AHA) Healthcare Provider CPR certification; Heart Saver, Rescue and Military training network CPR; or the American Red Cross CPR certification (CPR) except Citizen and Animal classes and |
Clinical Research Professional certification (CCRP) issued by the Society of Clinical Research Associates. or
Clinical Research Coordinator certification (CCRC) issued by the Association of Clinical Research Professionals
|Physical Requirements/Demands of the Position|
|Sitting||Occasionally (6-33% or 3 hours)|
|Walking/Standing||Frequently (34-66% or 5.5 hours)|
|Stooping/Bending||Occasionally (6-33% or 3 hours)|
|Reaching - Shoulder Level||Rarely (1-5% or .5 hours)|
|Reaching - Below Shoulder||Frequently (34-66% or 5.5 hours)|
|Reaching - Above Shoulder||Rarely (1-5% or .5 hours)|
|Repetitive Actions - Pinch Forces||Pounds of force:|
|Repetitive Actions - Grip Forces||Pounds of force:|
|Repetitive Actions - Fine Manipulation||Frequently (34-66% or 5.5 hours)|
|Balance - Right Leg|
|Balance - Left Leg|
|Lifting - Floor to Waist||Number of lbs:|
|Lifting - Waist to Overhead||Number of lbs:|
|Lifting - Other||Occasionally (6-33% or 3 hours)||Number of lbs: 25-50|
|Carrying - Long Carry (>50 feet)||Number of lbs:|
|Carrying - Short Carry||Occasionally (6-33% or 3 hours)||Number of lbs: 25-50|
|Carrying - Right Carry||Number of lbs:|
|Carrying - Left Carry||Number of lbs:|
|Carrying - Push/Pull (Static Force)||Number of lbs:|
|Other:||Number of lbs:|
|Exposed to infectious diseases.|
|Clinical Research Coordinator|
Equal Opportunity Employer