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Clinical Research Lead - Orlando Health Cancer Institute

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 possible so that you can be present for your passions. “Orlando Health Is Your Best Place to Work” is not just something we say, it’s our promise to you.


Position Summary


Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research.
Responsibilities:
Essential Functions
  • Manages division clinical programs and trial portfolio
  • Responsible for the execution and oversight of clinical trial operations from initiation through closeout
  • Mentor clinical research staff.
  • Serves as primary clinical operations contact with external and internal stakeholders.
  • Works with senior leaders to optimize staffing, workflow policies and procedures.
  • Develop process improvement initiatives enhancing OH clinical research programs and improve clinic flow
  • Triage and resolve clinical, research and data concerns.
  • Create and manage study management plans
  • Conduct disease/program specific meetings
  • Assess/approves Beacon Treatment Plans
  • Provide expert consultation an institutional level
  • Assists in training, developing, and evaluating performance of Clinical Research Coordinators I, II and III
  • 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).
  • 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 appropriate departmental and/or corporate meetings.
  • Attends study group and investigator meetings as required.
  • Conduct Quality Compliance Assessments
Qualifications:
Education/Training
  • Bachelor’s degree in a health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness
or Health Information Management, or other) and three (3) years related experience.
  • Associate degree in a health-related field (i.e. Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness
or Health Information Management) and four (4) years of directly related work experience may substitute for the
Bachelor’s degree (in additional to the requirements listed in the Experience section.
  • Graduate of an accredited allied health program and five (5) years 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 six (6) 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.
  • BLS/Healthcare Provider Certification required.
  • Maintains current CCRC/CCRP Certification (Certified Research Coordinator) by the Association of Research Professionals or
SOCRA (Society of Clinical Research Associates).


Experience
  • Bachelor’s Degree with minimum of three (3) years of clinical or research experience required; or a master’s degree in
health-related field may substitute for up to three (3) years clinical research experience. A Medical certification in specialty
with 15 years minimum clinical research experience or 10 years with a CRC certification.

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