Clinical Research Coordinator II - Orlando Health Cancer Institute

Orlando Health•Orlando, FL

15h

About The Position

Develops, coordinates, and implements research and administrative strategies essential to managing clinical trials research at Orlando Health Cancer Institute. Coordinates multi-site or large-scale clinical trials conducted by supervising principal investigators in support of assigned research protocols. The role includes assessing patients for protocol eligibility, coordinating protocol procedures, monitoring patient responses and adverse reactions, providing patient and family education, and helping ensure adherence to FDA and protocol guidelines. The coordinator prepares reports and regulatory documents, assists with protocol amendments and treatment orders, supports site audits, provides educational in-services, and promotes cooperation across departments. The position also requires attendance at relevant departmental, corporate, study group, and investigator meetings and use of department-specific computer software.

Requirements

Minimum of one year of clinical research experience.
Meet one of the following education or experience pathways: a bachelor's degree in a health-related field; an associate degree in a related field plus one year of clinical research or healthcare experience in addition to the experience requirement; graduation from an accredited allied health program plus one year of clinical research or healthcare experience in addition to the experience requirement; or, without a degree, qualifying experience substituted at a two-for-one ratio, with at least two years of clinical research experience.
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 CCRC/CCRP certification through the Association of Research Professionals or SOCRA within one year of hire.
BLS/Healthcare Provider certification required.

Responsibilities

Coordinate multi-site or large-scale clinical trials research studies conducted by supervising principal investigators in support of assigned research protocols.
Assess patients for protocol eligibility and communicate findings to the investigator or physician.
Coordinate implementation of protocol procedures.
Operate specialized equipment as needed in the assigned area, if applicable.
Assess and monitor patient responses and adverse reactions, and report them to accountable sources.
Provide appropriate patient and family education.
Complete reports, documents, and correspondence for regulatory agencies, participating clinical trial sites, and internal purposes.
Collaborate with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines, identify potential problems or inconsistencies, and take appropriate action.
Assist in preparing and submitting clinical trial protocol amendments to the IRB.
Provide educational in-services as needed.
Promote interdepartmental cooperation and coordination for each protocol.
Maintain reasonably regular and punctual attendance consistent with applicable policies and standards.
Maintain compliance with Orlando Health policies and procedures.
Assist in developing treatment orders for active studies for review by the treating physician.
Assist the research team in preparing for site audits.
Attend appropriate departmental and/or corporate meetings.
Attend study group and investigator meetings as required.
Demonstrate ability to use computer software specific to the department.