Clinical Research Coord - Full Time - Day - Corp

A Brief Overview

Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research

Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you.

Section 1557 Non-Discrimination
The Office for Civil Rights (OCR) enforces Section 1557 of the Affordable Care Act (Section 1557), which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex (including pregnancy, sexual orientation, gender identity, and sex characteristics), in covered health programs or activities. 42 U.S.C. 18116.

Qualifications

• Must meet one of the following:
• Bachelor’s degree in health-related field (i.e., Healthcare Administration, 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 two years clinical research experience required.
• Minimum of (1) year 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 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.

What you will do

• 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.