[Hiring] Travel Clinical Research Coordinator @Care Access

Role Description

The Travel Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, enrolling, and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. The 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.

How You'll Make An Impact

• Study Preparation:
  • Ability to understand and follow institutional SOPs.
  • Review and assess protocol, study manuals, and the investigator drug brochure for clarity, logistical feasibility, safety, inconsistencies, etc.
  • Assist PI, Regulatory, Start-up, and 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.
  • 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.
  • 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 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.
  • Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies.
  • Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary.
  • Collect and evaluate concomitant medications.
  • Collect, process, and ship biological specimens as directed by protocol.
  • Integrate monitoring visits and study teleconferences into existing work schedule.
  • 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 team.
  • Maintain effective relationships with study participants and other Care Access personnel.
  • Interact in a positive, professional manner with patients, sponsor representatives, investigators, and Care Access personnel.
  • 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 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 for completeness and alert values.
  • 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 and notify personnel as needed for procedures.
  • Dispense study medication per protocol and 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.
  • Accurately record study medication inventory, medication dispensation, and patient compliance.
  • 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 is 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.

Qualifications

• Bilingual proficiency required: Must be fluent in both English and Spanish.
• 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 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.
• 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.

Requirements

• BS in nursing, pharmacy, or other related science or combination of equivalent education 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.