Note: The job is a remote job and is open to candidates in USA. Florida Medical Clinic Orlando Health is seeking a Clinical Research Coordinator II to develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research. The role involves coordinating clinical trials, assessing patient eligibility, and ensuring compliance with FDA and protocol guidelines.

Responsibilities

• 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.
• 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.
• Demonstrates ability in using computer software specific to department.

Skills

• 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.
• All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director.
• Must be eligible for Certified Research Coordinator CCRC/CCRP by the Association of Research Professionals or SOCRA (Society of Clinical Research Associates within one year of hire.
• BLS/Healthcare Provider certification required.

Education Requirements

• Bachelor’s degree in health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or

Benefits

• Tuition reimbursement
• Public Service Loan Forgiveness (PSLF)
• Leadership development programs
• Comprehensive medical, dental, vision, free virtual visits, and well-being programs
• Up to 5% employer match on retirement contributions
• Four weeks of paid parental leave
• PTO
• Flexible leave options
• Fertility benefits
• Adoption assistance
• Backup care for children/elders/pets
• Pet insurance

Company Overview

• Florida Medical Clinic Orlando Health is a multi-specialty clinic that provides area residents with a resource for the latest advances in patient care. It was founded in 1993, and is headquartered in Zephyrhills, Florida, USA, with a workforce of 1001-5000 employees. Its website is https://floridamedicalclinic.com.

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