Clinical Research Coordinator III

• Patient Coordination 
  • Manages some of the sites most challenging therapeutic areas and study designs   
  • High complexity; intensive assessments, multi‑arm trials, frequent sponsor interaction.  
  • Champions balancing protocol needs with patient experience and safety across studies; models best practices.   
  • Can operate as solo CRC onsite. 
  • Prescreen study candidates   
  • Obtain informed consent per Care Access SOP 
  • Complete visit procedures in accordance with protocol.  
  • Complete basic clinical procedures per protocol, such as blood draws, vital signs, ECGs, etc.  
  • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.  
  • Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.  
  • Prioritize activities with specific regard to protocol timelines  
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.  
  • Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.  
  • Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)  
• Documentation 
  • Record data legibly and enter in real time on paper or e-source documents   
  • Accurately record study medication inventory, medication dispensation, and patient compliance.  
  • Resolve data management queries and correct source data within sponsor provided timelines  
  • Assist regulatory personnel with completion and filing of regulatory documents.  
  • Assist in the creation and review of source documents.  
• Patient Recruitment 
  • Assist with planning and creation of appropriate recruitment materials.  
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.  
  • Actively work with recruitment team in calling and recruiting subjects   
• Site Support 
  • Primary point of contact for the site  
  • Supports Key Sponsors and CROs  
  • Responsible for mentoring and training CRAs and CRC I/CRC II to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities  
  • Supports training and process improvements. 
  • Assist Regional Site Director, Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits  
  • Develops and maintains CAPAs, when needed, with approvals from the Regional Site Director 
  • Review and assess protocol (including amendments) for clarity, logistical feasibility   
  • Sets quality standards; prepares for audits; leads corrective actions.   
• Other Responsibilities:
  
  • Leads complex studies; coaches team; influences site operations.   
  • Ensure that all training and study requirements are met prior to trial conduct.  
  • Communicate clearly verbally and in writing.  
  • Attend Investigator meetings as required.   
  • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)  
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.  
  • Maintain effective relationships with study participants and other care Access Research personnel.  
  • Demonstrate deep knowledge about the therapeutic area of responsibility including comprehensive understanding of related Protocol designs, outcomes and timelines  
  • Drives improvements; removes barriers; mentors others through change.   

• Ability to understand and follow institutional SOPs.  
• Excellent working knowledge of medical and research terminology  
• Excellent working knowledge of federal regulations, good clinical practices (GCP)  
• Ability to communicate and work effectively with a diverse team of professionals.  
• Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail  
• Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.  
• Critical thinker and problem solver  
• Friendly, outgoing personality; maintain a positive attitude under pressure.  
• High level of self-motivation and energy  
• Excellent professional writing and communication skills  
• Ability to work independently in a fast-paced environment with minimal supervision.  
• Engage in continuous independent learning within the therapeutic area of responsibility 
• Leads cross‑site communications; represents site with sponsors/CROs.   
• Highly autonomous; leads study execution and resolves operational challenges independently

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Bachelor’s Degree preferred, or equivalent combination of education, training and experience.  
• Minimum Experience:
  • A minimum of 5 years prior Clinical Research Coordinator experience required  
  • Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator    
  • Recent phlebotomy experience required  

 

Mandatory Employer Disclosures

Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.