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Clinical Research Coordinator
3 months ago
**What We Do**
- Care Access is delivering the future of medicine today Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
**Who We Are**
- We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
**Position Overview**
- The Clinical Research Coordinator conducts daily site operations according to CARE SOPs, GCP and FDA/ICH Guidelines.
**What You'll Be Working On**
- Duties include but are not limited to
**Study Preparation**:
- Ability to understand and follow institutional SOPs
- Ability to perform all duties of Assistant CRC
- Learn to review and assess protocol (including amendments) for clarity, logístical feasibility, safety, inconsistencies, etc.
- Assist PI, Training Department, and the Trial Activation 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 office flow with Investigator and site staff
- Assist with planning and creation of appropriate recruitment materials
- Participate in Investigator meetings.
- Coordinate pre-study site visits with clinical staff and Sponsor/CRO representatives
- Assist in the creation or review of sponsor provided 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)
- Ensures that IRB approval is obtained prior to study initiation
**Study Management**:
- Integrate new trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines
- Maintain organized file for blank source documents, patient charts, CRFs and supplies
- Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
- Collect and evaluate concomitant medication
- 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
- Develop and maintain effective relationships with study participants and other care Access Research personnel
- Learn to interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
- Communicate clearly verbally and in writing
- Accept accountability for actions and function independently
**Patient Coordination**:
- 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
- Collect and evaluate medical records
- Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
- Be prepared to 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
- Learn to recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor and regulatory coordinator Able to submit reportable events to IRB as required.
- 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, medic
