Kalispell Regional Healthcare Certified Clinical Research Coordinator - Logan Health Research in Kalispell, Montana
Conduct safe and ethical clinical trials in compliance with FDA regulation, ICH Guidelines, KRH policies and procedures and applicable industry standards. Work under the general supervision of clinical trial investigators responsible for the clinical trials and the director of clinical research.
*Regulatory: Supports study start up and close-out. Processes study alerts, protocol revisions, amendments, accrual suspension notices, study marketing and related memoranda. Supports the development and modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level . Prepares for and participates in required sponsor and regulatory audits. Attends Investigator meetings as required to assure seamless study start-up. Assures that IRB reporting, authorization and documentation guidelines are met. Assists the leadership and legal team with budget preparation and contract oversight.
*Screening and Recruitment: Maintains surveillance system to identify potential subjects for study eligibility, prescreens patients and assists physicians in determining eligibility. Identifies new patients who are potential candidates for protocols by reviewing provider/investigator’s patient population, identifies relevant clinical trials, reviews and mines patient records, reviews clinic schedules and works closely with the multi-disciplinary team to identify potential study subjects prior to patient visits.
*Obtains informed consent according to GCP and ICH guidelines. Ensures that patients are appropriately consented and consent documents are appropriately maintained. Available to consent and enroll the patient at the time of the clinic visit.
*Study coordinating: Performs study procedures and assessments following protocol specific guidelines. Manages treatment and follow-up schedules to assure protocol compliance. Assures that patient meets all inclusion/exclusion criteria and the study subject has met all study eligibility requirements and all study visits, exams and procedures meet the protocol specifications for the clinical trial. Works closely with study subjects, families and other members of the multidisciplinary care team to assure protocol adherence. Coordinates patient study visits with the investigator working with clinic office staff to complete and schedule the required assessments and tests with a goal to consolidate scheduling for the convenience of the patient and to expedite study workup. Provides timely notification of diagnostic test and lab results to the investigator and sponsor.
*Meets sponsor specified data collection and CRF completion guidelines and timelines.
*Drug Accountability: Tracks study drug compliance per protocol and oversees study drug supply, shipments, destruction and randomization.
*Specimen Processing: Responsible for collecting and processing tissue, blood and biological specimens for shipment and disposition per protocol and IATA regulations (IATA certification as required). Timely notification of laboratory and test results to the principal investigator and research study subjects.
*Education: Educates subjects concerning diagnosis and treatment plan. Thoroughly explains the informed consent and study procedures, including HIPAA authorizations. Evaluates and develops subject education materials and provides subjects and/or family member’s instruction on drug administration and other study specific medical information. Educates patients regarding protocol diagnostic tests and assists with appointments. Provides education to support staff and multi-disciplinary team to assure protocol adherence.
*Compliance and Billing. Assures that a coverage analysis is in place at study start up. Works closely with billing and finance departments to assure appropriate billing compliance. Assures that auditors/monitors have the appropriate authorization for access to the medical records and meets organizational compliance guidelines.
*Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the position.
*Keeps current with new developments in research methodologies. Assures that KRH research web page is up to date for specific area of specialty.
*Notifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects. Reports serious adverse events according to GCP, ICH, FDA and industry guidelines. Performs initial interview during each subject visit and plans appropriate care under direction of the provider/investigator. Assures that patient safety is strictly monitored and Principal Investigator is kept informed.
Bachelors of Science degree in related field preferred or equivalent research experience. Nursing degree or license in related clinical field preferred.
Current Certification in Clinical Research (i.e. CCRC or CCRA) required. *May consider a non certified clinical research coordinator with appropriate education and research experience.
Current CPR Certification within 90 days of hire.
Minimum of two years clinical research experience required. Clinical experience in the research specialty preferred (i.e. cardiology, oncology, endocrinology, rheumatology, pain management, etc.)
Current IATA Certification required (specimen shipping) – within 30 days of employment.
Successful attainment of Phlebotomy Certification within one (1) year of employment.
Experience working with multi-disciplinary teams preferred.
Strong computer skills specifically with data bases preferred. Strong critical thinking skills.
Kalispell is a dynamic community located within a thirty-minute drive of Flathead Lake, Whitefish Mountain Ski Resort, Glacier National Park, several National and State forests and parks, and the Bob Marshall Wilderness area. Kalispell is the retail, professional, medical, and governmental center of the Flathead Valley serving approximately 140,000 people in Northwest Montana.
Job Locations US-MT-Kalispell
Requisition ID 2021-10115
Category Licensed (non-nursing)
Pay Period Status 80
Shift Start Hours 7:00 AM
Shift End Hours 5:00 PM
Position Type Full Time (Benefits Eligible)