Care Access · 3 days ago
Travel Clinical Research Coordinator
Orlando, Florida, United States
Full-time
Hybrid
Mid, Senior Level
$70K/yr - $100K/yr
3+ years expCare Access is working to make the future of health better for all. The Travel Clinical Coordinator is responsible for utilizing Good Clinical Practices in the process of screening, enrolling, and monitoring clinical research study subjects while ensuring protocol and regulatory compliance.
Clinical TrialsHealth Care
No H1B
Responsibilities
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
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
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
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
Qualification
Required
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
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
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
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
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
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
Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home
Preferred
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
Benefits
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
Company data provided by crunchbase