Travel Clinical Research Coordinator

The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access decentralized clinical research process the Travel Clinical Coordinator will be able to assume a greater study workload overall study responsibility and more detailed Site Sponsor and CRO interactions while conveying a positive image of Care Access Research to the community Sponsors CROs and study participants and their family members.

The Travel Clinical Coordinator is proficient at ICH/GCP Good Documentation Practices (GDP) and ALCOA-C. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead Site Manager Senior Manager and other leaders within clinical operations.

• Study Preparation:
  • Ability to understand and follow institutional SOPs
  • Review and assess protocol study manuals and the investigator drug brochure (including amendments) for clarity logistical feasibility safety inconsistencies etc.
  • Assist PI Regulatory Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
  • Discuss study medication required procedures eligibility criteria and impact on clinic flow with your manager Investigator and site staff
  • Assist with planning and creation of appropriate recruitment and marketing materials
  • Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam CRIO etc.
  • Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
  • Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
  • Assist in the creation or review of protocol specific source documents
  • Determine facility equipment and outsource vendor requirements and availability
  • Ensure adequate supplies have arrived on site for protocol initiation (lab kits study medication specialized equipment IVRS/EDC access and passwords) and study maintenance
  • Ensure education of Assistant CRCs research assistants site staff and/or sub-investigators is completed for required tasks
• Study Management:
  • Integrate new therapeutic more complex trial load with existing trial load delegate tasks as necessary and prioritize activities with specific regard to protocol timelines and participant safety.
  • Maintain organized file for source documents patient charts CRFs regulatory and study supplies
  • Where appropriate Investigational Product Accountability: receive inventory dispense monitor patient compliance and reorder as necessary. Document on accountability log and patient records
  • Collect and evaluate concomitant medications
  • Collect process and ship biological specimens as directed by protocol and/or laboratory manual.
  • Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
  • Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
  • Communicate sponsor updates patient specific concerns/progress unforeseen issues and overall trial management with appropriate members of Care Access Research team in an ongoing fashion
  • Maintain effective relationships with study participants and other Care Access Research personnel
  • Interact in a positive professional manner with patients sponsor representatives investigators and Care Access Research personnel and management
  • Strong and clear communication skills both verbally and in writing
  • Accept accountability for actions and function independently
• Patient Coordination:
  • Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
  • Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial
  • Administer delegated study questionnaires where appropriate.
  • Collect and evaluate medical records with the support of medically qualified members of the study team.
  • Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
  • Train others and complete basic clinical procedures 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
  • Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
  • Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
  • Schedule patients within visit windows notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
  • Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
  • Monitor patient progress on study medication

• Documentation:
  • Record data legibly in real time on source documents; note additional information that may assist with causality of adverse events explain protocol deviations or document patient progress. Correct errors per SOP
  • Accurately record study medication inventory medication dispensation and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
  • Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
  • Accurately transcribe data to CRF or EDC.
  • Resolve data management queries and correct source data as needed
  • Record protocol exemptions and deviations as appropriate with sponsor.
  • Complete Note(s)-to-File for patient chart and regulatory filing if necessary
  • Ensure all sponsor correspondence (e-mail telephone conversations) are printed and given to appropriate personnel for regulatory filing
  • Maintain copies of patient-specific correspondence in source charts
  • Assist regulatory personnel with completion of continuing/final review reports
• Perform other duties as assigned.

• Excellent working knowledge of clinical trials medicine and research terminology
• Excellent working knowledge of federal regulations good clinical practices (GCP) good documentation practices (GDP) and ALCOA-C
• 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.
• Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO clinical conductor Clinical Ink; EDC systems like MediData Oracle and Inform; ePRO eConsent and IWRS/IXRS etc.
• 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

Certifications/Licenses Education and Experience:

• BS in nursing pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
• RN or LPN preferred
• Research Professional Certification- CRCC or exam eligibility preferred
• A minimum of 3 to 4 years Clinical Research experience
• A minimum of 2 years prior Clinical Research Coordinator experience management level preferred.