Clinical Research Coord I - Jewitt Orthopedics

Orlando Health•Wesley Chapel, FL

18h

About The Position

Orlando Health Jewett Orthopedic Institute West Region Position Title: Clinical Research Coordinator I Department: Orthopedics Status: Full Time - Monday -Friday, 8:00 AM to 5:00 PM. Location: This position travels to Wesley Chapel, Tampa and Zephyrhills. Position Summary: Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research. Why is Orlando Health your best place to work? - Education & Career Growth – Tuition reimbursement, Public Service Loan Forgiveness (PSLF), and leadership development programs. - Health & Wellness – Comprehensive medical, dental, vision, free virtual visits, and well-being programs. - Financial & Retirement – Up to 5% employer match on retirement contributions. - Work-Life Balance – Four weeks of paid parental leave, PTO, and flexible leave options. - Family & Pet Support – Fertility benefits, adoption assistance, backup care for children/elders/pets, and pet insurance Qualifications Essential Functions  Participate in the coordination of 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.  Demonstrates ability in using computer software specific to department.  Support the team of data managers by answering complex questions and entering information into the EDC if necessary.

Requirements

Bachelor’s degree in health-related field (i.e., Healthcare Administrative, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or
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 one-year 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.
BLS/Healthcare Provider certification required.
One (1) year of healthcare experience required

Responsibilities

Participate in the coordination of 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.
Support the team of data managers by answering complex questions and entering information into the EDC if necessary.