Clinical Research Coord - Day - Full Time - Corp
Behavioral Health Market Context
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Job Description
Position Summary
Department: Clinical Research Coord I
Shift: Day / Full Time
Location: Orlando
Title: Clinical Research Coordinator I
Summary: Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research.
Education/Training: 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.
Licensure/Certification
• All RN’s 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. Experience · One (1) year of healthcare experience required.
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 in clinical trial sites and for internal purposes.
· Collaborate 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.
Department: Clinical Research Coord I
Shift: Day / Full Time
Location: Orlando
Title: Clinical Research Coordinator I
Summary: Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research.
Education/Training: 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.
Licensure/Certification
• All RN’s 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. Experience · One (1) year of healthcare experience required.
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 in clinical trial sites and for internal purposes.
· Collaborate 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.
Qualifications
- •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
- •BLS/Healthcare Provider certification required
- •One (1) year of healthcare experience required
Responsibilities
- •Shift: Day / Full Time
- •Summary: Participate in the development, coordination and implementation of research and administrative strategies essential to the management of clinical trials research
- •All RN’s and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director
- •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 in clinical trial sites and for internal purposes
- •Collaborate 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