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Develop and implement administrative strategies to manage clinical trials and coordinate large-scale research studies. Responsibilities include assessing patient eligibility, monitoring adverse reactions, and ensuring adherence to FDA and protocol guidelines.
Requirements summary
Requires a Bachelor's degree in a health-related field, or an Associate degree/allied health certification combined with one year of clinical research experience. Candidates without a degree must have at least two years of clinical research experience.
associate degreebachelor degreePatient AssessmentPatient EducationRegulatory ReportingProtocol ImplementationData MonitoringIRB SubmissionFDA Guidelines ComplianceClinical Trial CoordinationClinical Research DocumentationMulti-site Study Management
Job description
Position Summary
As a top cancer care provider in Florida, Orlando Health Cancer Institute is a comprehensive, multidisciplinary cancer program consisting of six treatment sites and more than 10 practice locations that serve the region’s adult oncology needs.
Specializing in more than 200 types of cancer, an expert team of medical professionals provides personalized care with the most state-of-the-art technologies, such as advanced radiation and proton therapies, and bone marrow transplant and cellular therapy.
Through a robust research program, the institute also supports physician involvement in numerous research studies and clinical trials that give patients access to innovative diagnosis, treatment and symptom management options.
In addition to being accredited by the Commission on Cancer, a program of the American College of Surgeons, Orlando Health Cancer Institute has earned accreditations and certifications in several areas — including medical oncology and hematology/oncology, radiation oncology, cellular therapy, rectal cancer, and breast care — from the respective accrediting organizations, and recently was named in the 2023 Becker's Hospital Review “60 Hospitals and Health Systems with Great Oncology Programs” list.
Orlando Health Cancer Institute is part of the Orlando Health system of care, which includes 24 award-winning hospitals and ERs, 9 specialty institutes, 14 urgent care centers, 100+ primary care practices and more than 60 outpatient facilities that span Florida’s east to west coasts and beyond.
Collectively, we honor our 100-year legacy by providing care for more than 142,000 inpatient and 3.9 million outpatient visits each year.
Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life.
We begin your benefits on day one and offer flexibility wherever poss.
Position Summary
Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research. Work schedule: Monda - Friday, 8:00 am - 5:00 pm Located: Downtown, 11 Columbia St.
Responsibilities
Essential Functions
Coordinate multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
Benefits
Free Education Programs
Well-being Services
Assesses patients for protocol eligibility and communicates findings to investigator/physician.
Coordinates the implementation of protocol procedures.
Operates specialized equipment as needed in assigned area, if applicable.
Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
Provides appropriate patient and family education.
Completes a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
Provides educational in-services as needed.
Promotes interdepartmental cooperation and coordination for each protocol.
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state, and local standards.
Maintains compliance with all Orlando Health policies and procedures.
Other Related Functions
Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
Assists the research team in preparing for site audits.
Attends study group and investigator meetings as required.
Demonstrates ability in using computer software specific to department.
Qualifications
Education/Training Must meet one of the following
Bachelor’s degree in health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or
Associate degree in related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management) and one (1) year of clinical research or healthcare experience (in addition to the requirements listed in the Experience section); or
Graduate of an accredited allied health program and one (1) year of clinical research or healthcare experience (in addition to the requirements listed in the Experience section).
If no degree, experience may be substituted at a two for one ratio and a minimum of two years clinical research experience required.
Licensure/Certification
All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director.
