Clinical Research Coord III

Position Summary:

Orlando Health - Clinical Research Corp

Title: Clinical Research Coord III

Orlando Health is one of Florida’s most comprehensive private, not-for-profit healthcare systems providing access to nearly two million Central Florida residents and has provided care for more than 4,600 international visitors annually. Our physician practices, diagnostic centers, hospitals and advanced medical treatments and procedures, along with our highly qualified team of medical specialists, have distinguished Orlando Health as a healthcare leader.

The Corporate Office of Research Oversight Clinical Research Coordinator III position will primarily work with auditing and monitoring of research projects enterprise wide. The coordinator will also develop, organize, and implement research and administrative/ compliance strategies essential to the management of clinical trials research across all divisions .

Essential functions will include:

• 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).
• Assist in education sessions, training, developing, and supervising the work of the Clinical Research Coordinators I, II & III.
• Collaborate with physicians, assesses patients for protocol eligibility and communicates findings to investigator/physician while working together with other healthcare staff to ensure adherence to FDA and protocol guidelines.
• Perform a variety of duties involving standardization/ implementation of operating procedures across all trials.
• Conduct independent Good Clinical Practice / protocol and regulatory reviews and facilitate monthly Good Clinical Practice and Audit Readiness review meetings with Quality Assurance Consultants.
• Perform compliance monitoring duties to include internal auditing and assisting the research team in preparing for external site audits as per the guidelines of the Corporate Office of Research Oversight.
• Complete a variety of audit reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
• Attend study group and investigator meetings as required and provides educational in-services as needed.

Responsibilities:

• Evaluates patients, gathering data from the patient, the physician, interdisciplinary team meetings if available, family and

• Develops treatment plans which integrate with the continuum of care and have specific goals and objectives and treats

• Demonstrates competency in the use, care and maintenance of profession specific equipment, observing safety precautions and

• Demonstrates knowledge and skills necessary to treat and provide care appropriate to the age of the patients served on the assigned caseload.
• Re-evaluates and modifies treatment plan and goals when appropriate.
• Demonstrates knowledge of the principles of growth and development over the life span.
• Assess data reflective of the patient’s status and interprets the appropriate information needed to identify each patient’s requirements relative to his or her age-specific needs.
• Provides care as described in the unit’s/area’s/department’s policies and procedures.
• Demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her

• Adheres to State Practice Act and Standards of Practice.
• Ensures complete documentation and accurate billing.
• Provides patient/family education as indicated.
• Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state

• Maintains compliance with all Orlando Health policies and procedures.

• Maintains a positive and encouraging treatment environment.
• Demonstrates caring, honesty, and open communication with all patients and coworkers.
• Maintains a professional appearance.
• Participates in Performance Improvement, program development, student supervision, assigned committees, safety, and

• Demonstrates an awareness of legal issues, patient rights, and compliance with regulatory and accrediting agencies.
• Practices efficient use and selection of supplies and equipment.
• Instructs and supervises supportive personnel in their duties.

Qualifications:

Education/Training:

• Bachelor’s degree in a health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness

• Associate degree in a health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness

• Graduate of an accredited allied health program and three (3) years of clinical research or healthcare experience (in

• 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:

• Conduct independent Audit experience min of Two (2) years.
• Two (s) years of clinical or research experience required.
• A Master’s degree in a health-related field may substitute for up to two (2) years clinical research experience