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Clinical Research Coord

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Orlando Health

1mo ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Orlando

AI generated summary

  • You must have a relevant degree or equivalent experience, BLS certification, one year of healthcare experience, and research experience. Direct patient caregivers may need medical director licensing.
  • You will coordinate clinical trials, assess patient eligibility, monitor responses, ensure protocol compliance, prepare reports, educate patients, and assist with audits and documentation.

Requirements

  • Must Meet One Of The Following
  • 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
  • Research 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.

FAQs

What is the primary responsibility of a Clinical Research Coordinator?

The primary responsibility of a Clinical Research Coordinator is to participate in the development, coordination, and implementation of research and administrative strategies essential to the management of clinical trials research.

What kind of education or training is required for this position?

Candidates must meet one of the following: a Bachelor's degree in a health-related field, an Associate degree in a related field with one year of clinical research or healthcare experience, or graduation from an accredited allied health program with one year of clinical research or healthcare experience. If no degree, experience may be substituted at a two-for-one ratio, with a minimum of one year of clinical research experience required.

Is certification required for this role?

Yes, BLS/Healthcare Provider certification is required. Additionally, RNs and other Clinical Research Coordinators involved in direct patient care may need to be licensed by the medical director.

What type of experience is necessary for this job?

A minimum of one year of healthcare experience is required, along with research experience.

What are the essential functions of the Clinical Research Coordinator?

Essential functions include coordinating clinical trials, assessing patient eligibility, implementing protocol procedures, monitoring patient responses, maintaining regulatory compliance, assisting in the preparation for audits, and collaborating with healthcare staff to ensure adherence to FDA and protocol guidelines.

Will the Clinical Research Coordinator have patient interaction?

Yes, the Clinical Research Coordinator will assess patients for protocol eligibility, monitor their responses and adverse reactions, and provide education to patients and their families.

Are there opportunities for additional training or education?

Yes, the Clinical Research Coordinator may provide educational in-services as needed and is expected to stay updated with departmental and corporate meetings.

What kind of reports and documentation will the Clinical Research Coordinator complete?

The Clinical Research Coordinator will complete various reports, documents, and correspondence for regulatory agencies, participating clinical trial sites, and for internal purposes.

Is attendance important for this position?

Yes, maintaining reasonably regular, punctual attendance is required consistent with Orlando Health policies and applicable laws.

Can you explain the interdepartmental cooperation requirement?

The Clinical Research Coordinator is expected to promote interdepartmental cooperation and coordination for each protocol, ensuring effective collaboration between various teams involved in the clinical trials.

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Orlando Health

A trusted leader inspiring hope through the advancement of health.

Science & Healthcare
Industry
10,001+
Employees
1918
Founded Year

Mission & Purpose

Orlando Health is a not-for-profit healthcare organization with $7.6 billion of assets under management that serves the southeastern United States. Headquartered in Orlando, Florida, the system was founded more than 100 years ago.