Kalispell Regional Healthcare Manager, Clinical Research in Kalispell, Montana
Manages the day to day operations of the Kalispell Regional Healthcare (KRH) Clinical Research Department. Works in coordination with KRH leadership, staff, clinical trial investigators and providers, to ensure clinical trials are conducted safely, ethically and in compliance with FDA regulation, ICH Guidelines, Sponsor protocol requirements, KRH policies and procedures and applicable industry standards.
*Participates in and coordinates the day to day operations of the clinical research department in the inpatient, outpatient and regional settings.
*Completes and maintains staff scheduling. Manages department timekeeping performs timely staff performance evaluations and performance management. Ensures staff competency is up to date and quality control standards are maintained. Ensures that department SOPs are up to date and that all staff have current sign-off on SOPs. Develops staff training guidelines and facilitates continuing education opportunities. Keeps current with new developments in research methodologies. Ensures that KRH research web page is updated and maintained.
- Prepares and manages departmental operational budget development and oversight. Identifies budget needs and provides capital equipment budget recommendations. Serves as primary contact for implementation of new systems/upgrades.
*Manages departmental procedure and service billing, maintains billing in Meditech, reports monthly activity to Director and Finance department and creates clinical and financial reports as needed.
*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. 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.
*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. Ensuresthat patients are appropriately consented and consent documents are appropriately maintained.
*Performs study procedures and assessments following protocol specific guidelines. Oversees treatment and follow-up schedules to assure protocol compliance. Assures 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 withclinic office staff to complete and schedule the required assessments and tests 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.
*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.
*Assures 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.
*Ensures that all investigators have appropriate training. Notifies principal investigator of any adverse and/or 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.
Other duties as assigned.This position description in no way states or implies that these are all the only duties required. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is a logical assignment to the position.
Bachelors of Science degree in related fieldorBSN required. Master’s degree in research related field, business or healthcare administration preferred.
Minimum of three (3) years’ leadership experience required. Minimum of two (2) years’ clinical research experience required. Experience working with multi-disciplinary teams preferred.
Current Certification in Clinical Research (i.e. CCRC or CCRA) required.
Current CPR Certification within ninety (90) days of hire.
Current IATA Certification preferred (specimen shipping), or must successfully obtain within thirty (30) days of hire.
Successful attainment of Phlebotomy Certification within one (1) year of hire required.
Excellent organizational skills, detail-oriented, a self-starter, possess critical thinking skills and be able to set priorities and function as part of a team as well as independently.
Strong computer skills specifically with data bases preferred.
Job Locations US-MT-Kalispell
Requisition ID 2020-7362
Pay Period Status 80
Shift Start Hours 8:00 AM
Shift End Hours 5:00 PM
Position Type Full Time (Benefits Eligible)