Research Coordinator I

Join Cleveland Clinic Weston Hospital’s team of caregivers that remain on the leading edge of technology and education all while consistently providing patient-centered healthcare. As part of Cleveland Clinic’s Florida region, Weston Hospital is recognized as one of the top hospitals in the Miami-Fort Lauderdale metro area and Florida. Here, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.   

Innovative research and groundbreaking discoveries happen every day at Cleveland Clinic. Each member of our team contributes to our mission of caring for life, researching health and educating those who serve. The ideal candidate demonstrates excellence in customer service, communication and attention to detail in the implementation and conduct of human subject research projects. The primary focus of the position is the Cleveland Clinic BioRepository and will require on-site duties at Cleveland Clinic's Weston Hospital as well as other sites within the Health System. We are needing someone who is bilingual (English/Spanish). ​

A caregiver in this position works 8:00AM – 5:00PM.  

A caregiver who excels in this role will:  

• Coordinate all aspects of clinical research trials including protocol feasibility review, IRB application, protocol budgetary preparation, patient recruitment, enrollment, patient consents, patient scheduling, visit tracking, maintaining all necessary documentation, primary contact for patients and sponsors, and coordination of monitoring visits. Coordinate the compliant implementation and conduct of human subject research projects typically of low workload and low complexity.

• Assist the Principal Investigator in all aspects of conducting trials.  

• May be required to work on multiple trials in various specialties depending on departmental needs. 

• Communicate information about the subject health and safety to CRC and/or Principal Investigator promptly and responsibly. 

• Observe regulations and ethical standards regarding human subject rights and welfare. 

• Communicate concerns regarding ethical violations to the Manager/Principal Investigator. 

• Implement and conduct multiple research projects in a timely and efficient manner. 

• Assist in preparation of IRB documents as requested. 

• Secure/order investigational devices or study supplies as necessary. 

• Prepare/create/OA source documents prior to study start and according to SOP's. 

• Collect data accurately and complete CRFs in a timely manner. 

• Oversee/coordinate IRB renewal process as necessary and keep abreast of due dates. 

• Ensure proper collection, processing and shipment of specimen. 

• Prepare on-site monitor visits, including pre-study, initiation, and closeout visits. 

• Assist as needed in preparing for FDA and internal audits. 

• Maintain and update essential documents as required by the FDA, IRB, Sponsor/CRO or any other regulatory agencies or funding agencies as necessary. 

• Ensure the preparation, submission and obtaining approval for any check request, purchase requisitions in accordance with study protocols and Cleveland Clinic Florida guidelines. 

• Assist with grant applications, compiling literature reviews or the preparation of abstracts, entering information and/or maintaining databases for research department, ordering patient charts and placing reminder calls to patients as necessary. 

• Promote patient recruitment by preparing patient mailers, postcards or mass communications and participating in presentations as necessary. 

• Screen and assign patients to appropriate research protocols. 

• Present scientific statements or endorsements related to investigational devices/drugs with full disclosure. 

• Submit the IND to the FDA for investigator-initiated studies and formulate/track regulatory documents necessary. 

• Conduct follow-up visits of research subjects to evaluate progress and educate them regarding protocol, adverse events and compliance issues as requested. 

• Report and record adverse events/severe adverse events to Regulatory Coordinator, IRB Sponsor and PI and other agencies as required.  

Minimum qualifications for the ideal future caregiver include:  

• Bachelor’s degree or three years of clinical research experience/training  

• Familiarity with medical terminology and procedures  

• Demonstrated clinical competency within 90 days  

• Phlebotomy skills or the ability/willingness to learn 

• Knowledge of all phases of the research process  

Preferred qualifications for the ideal future caregiver include:  

• Certified Clinical Research Coordinator (CCRC) 

• Experience working with federal regulations and IRBs 

Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we’re dedicated to providing what matters most to you: https://jobs.clevelandclinic.org/benefits-2/