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-winninghospitals 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.

Position Summary

A Research Site Development Coordinator II will be part of a team evaluating clinical trial opportunities for OHCI focusing on growing the oncology research portfolio and building strategic relationships with research partners. This will include facilitation and execution of confidentiality agreements, evaluation of feasibility, conduction of pre-site selection visits, coordination with external and internal stakeholders, and tracking of opportunities and outcomes. Serve as primary liaison with pharmaceutical sponsors, consortium partners,


national groups and vendors; manage deliverables to multi-disciplinary teams, oversee project agreements; and nurture external partnerships.

Located: Downtown, 11 West Colombia

Work schedule: Monday - Friday (fulltime)

Responsibilities:

Essential Functions

Lead in identification of and feasibility process for new clinical trials including evaluation of potential sites based on regulatory,
operational, and scientific criteria.

Coordinate the execution of confidentiality agreements for clinical trial opportunities. Lead discussions with Develop and lead site engagement strategies including multi-disciplinary Disease Working Group presentations, sponsor and or
sponsor representative calls, and site hosted pipeline events.


Interpret and apply clinical trial protocols to assess site capabilities. Lead site evaluation and completion of assigned feasibility assessments for clinical trials. Represent OHCI and the Research Office at required oncology and or other disease research, pharmaceutical sponsor, and
consortium at national and international meetings and conferences. Coordinate investigator and sponsor meetings ahead of and


throughout a conference in addition to attending meetings to scribe and serve as research start-up operations expert.


Primary liaison with internal or external clients, sponsors, or partners assigned studies, projects, or programs. Act as primary contact for all project matters; understand and organize contractual and organizational client expectations, nurture client relationships and needs. Provide the client regular reports on project status, certain metrics, and issues. Responsible for assigned project deliverables. Oversee progress by keeping close metrics, including but not limited to time and
quality. Prepare and present internal project status to management, disease working groups, and associated teams. Be accountable


for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues.


In cooperation with regulatory coordinators or project managers, organize and actively participate in sponsor/client site visits. Work
closely with new members of the clinical project management team.


Serve as an internal liaison to bridge projects from earlier preclinical project teams and their project managers to transition smoothly
to clinical stages. Analyze site performance and develop process improvement plans.


Act as a liaison between study sponsors, OHCI investigators and the Research Office by evaluating problems and providing solutions. Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and
ethical guidelines pertaining to the conduct of clinical research.


Promote a positive work environment that is maintained through open and effective communication. Serve as first point of contact for potential outside clients and maintain that relationship during current and future projects. Establish and foster strong relationships and interactions with OHCI investigators, the OHCI community, study sponsors and the
research office personnel.


Ensure high quality of data and metrics to study sponsors and research teams. Participates in training and mentoring of Site Development Coordinator I team members and contribute to SOP development Participates in clinical trial portfolio management including trial development to meet needs of OH Clinical Trials Office
investigators and OH catchment area.

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

Maintains compliance with all Research Office policies and procedures. Travel to required meetings and conferences.
Qualifications:

Education/Training

Bachelor's degree in pharmacy, pharmacology, pharmaceutics, nursing, science, or related field. Masters degree in pharmacy, pharmacology, pharmaceutics, nursing, science, or related field preferred. If an Associate's degree in related field(s), additional experience may be substituted. A minimum of 2 to 3 years of clinical research
experience required.

Licensure/Certification

Certified Research Coordinator CCRC/CCRP by the Association of Research Professionals or SOCRA (Society of Clinical Research


Associates) preferred.

Experience

Minimum of two to three years of clinical research experience. Oncology experience preferred Requires, project coordination, critical thinking, problem solving, relationship building and communication skills In-depth knowledge of GCP, FDA regulations, and clinical trial processes. * Excellent communication, negotiation, and leadership skills.