Travel Clinical Research Coordinator, US Based (Los Angeles, CA)
Care Access
- Los Angeles, CA
- Temporary
- Full-time
- 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.
- This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide.
- Duties may require travel in the following models:
- Two weeks on / One week off deployments
- Temporary Event Support (3-7-day deployment durations)
- Weekly deployments (one week on, 2-5 days off).
- Frequency and length of travel may depend on the length and location of study, site, and event.
- Deployments normalize to a 32 to 42-hour work week on average.
- 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.