Job Description Summary:

This position plays a key role in presenting treatment alternatives and assessment of treatment risks and benefits associated with clinical trials. The primary role is to coordinate, collaborate, educate and consult with principal investigators, sub-investigators, patients, families, and various other health care professionals to ensure all protocol specifications are appropriately carried out in compliance with FDA, ICH guidelines, Logan Health policies and procedures and applicable industry standards.

Qualifications:

• Minimum of one (1) of the following required:

• Current Montana Licensed Practical Nurse (LPN) licensure.

• Current Montana RN license or a multi state compact license with authorization to practice nursing within the state of Montana; required.

• Current Montana Advanced Practice Clinician (APC) licensure.

• Current Healthcare Provider CPR required.

• Current Good Clinical Practice (GCP) and Human Subject Research (HSR) Training preferred and must successfully obtain within thirty (30) days of hire.

• Current IATA Certification preferred and must successfully obtain within thirty (30) days of hire.

• Certification in Clinical Research through ACRP (i.e. CCRC or CCRA) must be successfully obtained within three (3) years of hire.

• Minimum of two years clinical research experience preferred.

• Oncology trial additional requirement:

• Oncology Nursing Society (ONS) Chemotherapy and Immunotherapy Fundamentals Provider Card must be successfully obtained within two (2) years of hire.

• Possess and maintain computer skills to include working knowledge of Microsoft Office Suite and ability to learn other software as needed. Strong database skills preferred.

• 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.

• Commitment to working in a team environment and maintaining confidentiality as needed.

• Excellent verbal and written communication skills including the ability to communicate effectively with various audiences.

• Excellent interpersonal skills with the ability to manage sensitive and confidential situations with tact, professionalism, and diplomacy.

Job Specific Duties:

• Trial and Regulatory Support:

• Works with the regulatory specialist to support the development and modification of informed consent forms in compliance with federal guidelines for patients.

• Assists with study budget preparations, negotiations, contract oversight and ensures coverage analysis is in place.

• Assists to maintain accurate documentation of each study and communicates with the principal investigator about study-related issues per department protocol. Assists Certified Coordinators with data entry and query resolution.

• Meets with monitor/auditors during visits to discuss case report form completion, query resolution and other protocol-related issues. Ensures access to medical records in compliance with Logan Health guidelines.

• Assessments and Adverse Event Reporting:

• May assess the patient’s ability and willingness to follow and complete study procedures and visits. Ensures patients are properly consented according to GCP and International Council on Harmonization (ICH) guidelines and records are appropriately maintained.

• May assess patient for possible toxicities and side effects of study intervention, evaluates adverse events, records concomitant medications, and assesses patient compliance.

• Recognizes and reports laboratory values and alerts to investigator and sponsor in timely manner. Utilizes adverse event assessment data and clinical judgement to determine dose modifications per trial specifications and collaborates with the investigator. Reports all adverse events per study protocol.

• May provide nursing care to patients, to include drug administration.

• Communication and Education:

• Initiates collaboration and education of interdisciplinary team involved in patients care to ensure all necessary parties are well informed and adhere to protocol specifications.

• Continually provides education to patient and/or family regarding treatment plan, expected side effects, approved interventions and assessments needed throughout patient participation in the clinical trial.

• Acts as a liaison between the provider and the patient. Identifies and recommends appropriate referrals to other disciplines as indicated.

• Compliance:

• Assists with the preparation and submission of institutional review board (IRB) documents.

• Ensures all documents are obtained and completed as required by trial protocols.

• Provides timely notification of Serious Adverse Events to the appropriate stakeholders per clinical trial protocol.

• Works with billing and finance to ensure appropriate billing compliance and identifies routine care vs research-related care.

• Specimen Processing and Drug Accountability:

• Collects and processes tissue, blood and biological specimens as applicable for shipment and disposition per IATA and protocol specifications in conjunction with Logan Health Lab and pathology personnel.

• Tracks study drug compliance per protocol specifications and oversees study drug supply, shipment, destruction and randomization in conjunction with Logan Health pharmacists as applicable.

• Advocates for patients and program and applies continuous quality improvement knowledge and skills.

• Exhibits knowledge and application of research policies, procedures and guidelines. Participates in organizational research activities to promote research within the organization.

The above essential functions are representative of major duties of positions in this job classification. Specific duties and responsibilities may vary based upon departmental needs. Other duties may be assigned similar to the above consistent with knowledge, skills and abilities required for the job. Not all of the duties may be assigned to a position.

Maintains regular and consistent attendance as scheduled by department leadership.

Shift:

Day Shift - 8 Hours (United States of America)

Schedule Details:

Please know schedules and shifts are subject to change based on patient care and department/organizational needs.

Schedule:

Logan Health operates 24 hours per day, seven days per week. Schedules are set to accommodate the requirements of the position and the needs of the organization and may be adjusted as needed.

Notice of Pre-Employment Screening Requirements

If you receive a job offer, please note all offers are contingent upon passing a pre-employment screening, which includes:

• Criminal background check

• Reference checks

• Drug Screening

• Health and Immunizations Screening

• Physical Demand Review/Screening

Equal Opportunity Employer

Logan Health is an Equal Opportunity Employer (EOE/AA/M-F/Vet/Disability). We encourage all qualified individuals to apply for employment. We do not discriminate against any applicant or employee based on protected veteran status, race, color, gender, sexual orientation, religion, national origin, age, disability or any other basis protected by applicable law. If you require accommodation to complete the application, testing or interview process, please notify Human Resources.

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