Supervisor Clinical Research Data

4 weeks ago

Orlando, United States Orlando Health Full time

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 regions 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 Floridas 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, its our promise.

*Oncology experience preferred*

*Clinical Trial Data experience preferred*

*Work schedule Monday - Friday 8:00 am - 4:30 pm*

*Location Downtown Orlando*

Position Summary


The Clinical Research Data Supervisor leads and supports staff in clinical research data coordination. Responsible for conducting and coordinating the involvement of other Clinical Research Data Coordinators in individual research projects.

Responsibilities:

Essential Functions


Supervises training and development of other research staff.
Oversees workflow of Clinical Research Data Coordinators
Works with team members in a manner that encourages them to assume ownership of their projects.
Acts as a resource in exceptional situations requiring immediate intervention as deemed necessary such as during and external agency audit.
Participates in orientation, training and skill development of new employees
Demonstrates exemplary customer service and leadership skills to include problem resolution and process improvement skills.
Serves as an ambassador of the Director, the Department and the Institution through relationships with outside collaborations (industry, cooperative groups and professional societies).
Provides updates to the Department Director on the status of study activities and data compliance.
Coordinates clinical research activities and investigations per department requirements.
Assess the conduct and progress of assigned clinical trials by monitoring compliance with protocol and clinical study schedule to ensure protocol compliance.
Demonstrates the ability to coach research staff and physicians regarding the research process, Code of Federal Regulations and Guidelines for Good Clinical Practiced (ICH-GCP).
Assesses the conduct and progress of assigned clinical trials by monitoring compliance with the protocol and clinical study schedule to ensure protocol compliance.
Assesses protocols and electronic data completion guidelines for accuracy and escalates/resolves any discrepancies.
Reviews monitoring or auditing reports for accuracy and resolves any discrepancies
Collaborates with physicians, clinical and regulatory supervisor, and other healthcare staff to ensure adherence to protocol requirements.
Promotes interdepartmental cooperation.
Performs quality control reviews on clinical research data staff members to ensure compliance, accuracy, and timeliness.
Manages various personnel functions including hiring, work assignments, coaching plans, and disciplinary actions.
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, stateand local standards.
Maintains compliance with all Orlando Health policies and procedures.


Other Related Functions


Participates in the recruitment of research staff
Assists in the development of source documentation
Assists in the development and monitoring of the budget process as needed.
Assists in the preparation of site audits
Attends appropriate departmental and/or corporate meetings, study group and/or investigator meetings as required.
Maintain flexible hours to meet clinical trial specific requirements, data locks and audits.
May be required to draw blood from existing peripheral IVs after appropriate Orlando Health training and competency check-off.
May schedule appointments and/or tests, after consulting with investigators for protocol compliance.
Able to discuss protocol participation with patients and keep them informed of procedures and changes to the study.
Assists in the reconsenting process by securing the necessary signatures.
Performs other duties as assigned.

Qualifications:

Education/Training


Associates degree with six (8) years experience in research OR;
Bachelors degree with four (4) years experience in research.
If no degree, experience may be substituted at a ratio of 2 years experience for one year of required degree.


Licensure/Certification


Certified Clinical Research Professional (SoCRA) OR Certified IRB Professional (PRIM&R), OR Certified Clinical Research Coordinator
(ACRP), OR Society for Clinical Data Management (SCDM)

Orlando Health phlebotomy course within 30 days of hire is required within certain areas.


Experience


Minimum 8 years research experience
Minimum 4 years direct clinical data experience

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