Clinical Research Coordinator

3 weeks ago

Bangor, United States Northern Light Health Full time

Northern Light Eastern Maine Medical Center Department: Clinical Research Position is located: Northern Light Eastern Maine Medical Center Work Type: Full Time Hours Per Week: 40.00 Work Schedule: 7:30 AM to 4:00 PM Summary: In CancerCare of Maine, the Clinical Research Coordinator (CRC) works closely with the research team to ensure excellent quality and safety for patients with oncology/hematology disorders who participate in prevention, treatment, and tissue collection trials /projects. The CRC will work with healthcare providers, multiple departments and outside facilities to coordinate projects, streamline processes and provide patient coordination support, as well as manage regulatory requirements for research. The CRC is challenged to continually learn while working closely with adults and children who utilize the surgical, medical oncology, and radiation oncology services. Responsibilities: + Clearly, effectively, and respectfully communicates with patients, families, staff, physicians, and management. + Facilitates and coordinates relationships with external sources ie. other hospital physicians, staff, departments, administration and managements as needed. + Meets research mandated / local and sponsor requested IRB requirements without deviation. + Coordinates timely and accurate processing for protocol updates, amendments, A/E's, I/B's, etc. + Coordinates and assists with the preparation of cooperative group, industry or other projects, contributes to the evaluation of project feasibility, and implementation. + Is a ready resource to healthcare professionals for trials searches/questions. + Utilizes appropriate resources, delegates effectively to achieve successful and timely submissions of research data, implementation of projects or activations of clinical trials. + Coordinates and manages meetings, monitor-site visits /auditor visits- taking/distributing minutes. + Ensures timely follow-through and completion of tasks related to meetings, monitor-site visits, and auditor visits. + As required, appropriately consents patients to non-treatment research projects/protocols following the federal guidelines as mandated by the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GGCP). + Assists EMMCB, other departments, and patients with successful completion of research required tasks such as completing questionnaires, specimen collection and send outs, etc. + Submits required patient and/or regulatory data, documents independently, and accurately. Keeping source documents, ensuring that protocol requirements and guidelines are followed. + Manages and maintains patient and/or regulatory data bases so that they are accurate and current. + Appropriately refers clinical related tasks or questions to appropriate healthcare professionals. + Performs tasks as requested by supervisor/manager/director. + Identifies needs and assists in developing Departmental Directives and/or policies and procedures for accurate and safety related to research. + Maintains active and current knowledge of changing regulatory requirements for clinical research participation for the institution, the patient, and Review Boards) with appropriate and timely follow through for required amendments, renewals. Updates appropriately informs research team of these changes as needed. + Alerts physicians, nurses, pharmacists, pertinent staff, and other healthcare providers of all significant changes which require prompt or immediate attention such as: re-consenting or informing patients of new information or changes as requested by the sponsor(s). + Coordinates research team members, physicians and others for NIH training and other required sponsor trainings. Maintains these records and assists with maintaining NCI's Investigator licensure. + Develops, performs, and delegates routine Internal audits for such things as regulatory requirements, Reporting of Adverse Events, and data collection, reports results to research manager. + Maintains CCRP or CCRA certification. + Informs research manager of deviations as defined by GGCP and cooperative groups or sponsors to allow for process review and corrections as needed. + Assists in setting and reaching patient accrual goals - participates in improving/changing processes to achieve goals as needed. + Seeks and participates in educational opportunities related to the fields of research - clinical/translational/biologic and brings new information to the team. + Seeks and alerts Executive Director/Manager of new research opportunities for review and potential participation. + Coordinates sponsor budgets /tracking costs /contracts -works closely w/Executive Director/Manager + Tracks revenue received for timeliness/accuracy and reports to manager. + Assists in identifying costs related to projects/ protocols and works closely with the Executive Director/Manager to advise regarding labor costs and others as requested. + Ensures payment to billers/pt's of research covered costs (testing, etc). + Maintains databases for tracking revenue/payments/ works w/Accounting Services. Other Information: Competencies and Skills + Behaves with Integrity and Builds Trust: Acts consistently in line with the core values, commitments and rules of conduct. Leads by example and tells the truth. Does what they say they will, when and how they say they will, or communicates an alternate plan. + Cultivates Respect: Treats others fairly, embraces and values differences, and contributes to a culture of diversity, inclusion, empowerment and cooperation. + Fosters Accountability: Creates and participates in a work environment where people hold themselves and others accountable for processes, results and behaviors. Takes appropriate ownership not only of successes but also mistakes and works to correct them in a timely manner. Demonstrates understanding that we all work as a team and the quality and timeliness of work impacts everyone involved. + Practices Compassion: Exhibits genuine care for people and is available and ready to help; displays a deep awareness of and strong willingness to relieve the suffering of others. Education + Required Associate's Degree + Previous RN experience preferred Working Conditions + Need to drive to perform responsible duties. + Work with computers, typing, reading or writing. + Prolonged periods of sitting. Position Clinical Research CoordinatorLocation Req ID null

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