Clinical Research Coordinator

Position Summary

We are in search of a Clinical Research Coordinator (CRC) who will take full responsibility to initiate, implement and manage each research study assigned to them as well as maintain a working knowledge of all studies being conducted at the site in order to effectively screen and enroll subjects. The CRC will ensure study procedures are conducted as directed in the protocol. Patient safety will supersede all actions. The CRC will collect, evaluate, and report all study data using Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines as set forth by the Food & Drug Administration (FDA).

The CRC will conduct all studies with the Code of Federal Regulations (CFR) 21CFR Part 50 and 21CFR312.50, Subpart D, and per the Clearwater Cardiovascular Consultants (CCC) Research Department Standards of Practice (SOP’s).

What You Will Be Doing

INITIATE AND IMPLEMENT CLINICAL RESEARCH STUDIES

• Assist with evaluating prospective clinical research studies for scientific merit, safety, and feasibility.
• Initiate and implement each study protocol according to the specific requirements of the study and according to the guidelines set forth by the CCC Research Department’s SOP’s
• Train all personnel responsible for the care of research subjects or who may be impacted by the conduct of the trial.
• Assist in the preparation of regulatory documents
• Attend investigators meeting and accommodate sponsor site approval and initiation visits as required.
  
  

Manage Clinical Research Studies

• Keep PI informed on study.
• Implement effective systems for the screening and enrollment of eligible subjects in conjunction with department procedures and with the assistance of the research team.
• Communicate any changes in study procedures or amendments to the protocol in a timely manner to all affected personnel.
• Assist with development of study budget.
• Communicate study status with Director as needed.
• Schedule and execute study Monitor Visits
  
  

MANAGE SUBJECT CARE AS IT RELATES TO STUDY

• Educate subjects and their significant others of their responsibilities in the research study.
• Obtain informed consent from eligible subjects by providing complete disclosure of responsibilities, benefits and risks associated with study participation.
• Schedule subjects and perform protocol required visits.
• Provide detailed documentation of subject visits.
• Schedule study-related tests and procedures as appropriate. Evaluate results of such tests and have Investigator evaluate for relatedness as needed.
• Perform phlebotomy and/or supervise the collection and submission of laboratory samples as required by the study protocol.
• Process laboratory specimens and ship to appropriate laboratory.
• Monitor subjects for adverse events and clinically significant changes to Investigator
• Dispense investigational medications to study subjects and maintain drug accountability records.
• For in-hospital studies, communicate and work in conjunction with the hospital pharmacy, or appropriate department in maintaining, investigational drug/device supplies according to the protocol and within FDA regulations.
• At the closing of studies, assist subjects in securing continuity of care.
  
  

COLLECT, EVALUATE AND MAINTAIN STUDY DATA

• Collect and maintain research data as required by the protocol and GCP/ICH Guidelines
• Create worksheets.
• Complete electronic case report forms accurately and within Dept. SOP’s.
• Report adverse events and serious adverse events per GCP/ICH Guidelines
• Maintain accurate tracking logs of all visits and procedures.
• Maintain research data in an organized and logical manner in accordance with FDA regulations for the time periods required by sponsor and state and federal regulations.
• Meet with clinical monitors during site visits and report results to the Clinical Research Manager and Principal Investigator.
• Complete data clarification queries in a timely manner.
• Perform study close out procedures according to the department procedures and sponsor requirements.
• Prepare study documents for archiving at conclusion of study.
• Notify the IRB and submit progress and final reports as required by each IRB and according to FDA regulation.
  
  

PROMOTE CLINICAL RESEARCH AWARENESS WITHIN PRACTICE

• Review patient lists, procedure schedules and other information to identify potential study subjects.
• Disseminate information regarding research activities.
• Educate physicians, nurses and staff of new and ongoing studies and remind physicians of open enrolling studies.
• Be alert for and bring new study opportunities to Director.
  
  

Additional Responsibilities

In addition to the specific duties assigned for each study protocol, the CRC will be expected to maintain adequate understanding of each clinical research study protocol conducted, in order to effectively screen and enroll subjects, as well as act as a resource to hospital personnel and physicians.

• Provide assistance to other coordinators for their studies, including back-up visit coverage.
• Create memos, letters faxes, and other documents as required.
• All communication should be professional and polite.
• Handle phone calls from study subjects with concern, confidentiality, and efficiency.
• Maintain computer/equipment skills as required for appropriate study management.
• Attend regularly scheduled staff meetings.
• Share on-call responsibilities with other coordinators when necessary.
• Function as a member of the Research Team and maintain department priorities as outlined by the Director.
• The CRC will perform any study related duty that ensures the proper conduct and success of the study.
  
  

Who You Are

One year of adult clinical experience, critical care and cardiology preferred. Current Florida Medical License/Certification ex. LPN, RN RCIS, R(RT), RRT or equivalent. Bachelor’s Degree preferred. Excellent organizational skills with high attention to detail. Excellent verbal and written communications skills. Excellent Computer skills, including Excel, Word and Internet Explorer. Previous research experience preferred.

As a Team Member At Ccc, You’ll Enjoy

• 401(k) - 100% Match on the first 6% that you contribute
• Dental insurance
• Company Paid Disability Insurance
• Health insurance
• Company Paid Life insurance
• Paid time off
• Vision insurance
• Wellness Program
  
  

It is the Policy of ccc / CVL to ensure equal opportunity to all Team members, applicants or any other covered persons in all employment matters, including but not limited to recruitment, hiring, placement, compensation, benefits, training, promotion, transfer. CCC / CVL does not discriminate against any qualified individual because of actual or perceived race (including traits associated with race, for example, hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, age, national origin, ancestry, citizenship status, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, citizenship status, work authorization status.