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.
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
- 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, logistical 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
- Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database
- Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
- 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
- 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
- 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
- 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
- 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. Resolve data management queries and correct source data as needed utilizing ALCOA-C principles
- Record protocol exemptions and deviations as appropriate with the sponsor. Complete Memo-to-File for patient chart and regulatory filing if necessary
- When necessary, help coordinate the creation of CAPA plans as required and ensure their full and timely execution
- 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 initial submission, continuing and final review reports
- Reports suspected non-compliance to supervisor Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Physical and Travel Requirements
Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills and Abilities:
- Good working knowledge of medical and research terminology
- Good working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent organizational skills with strong attention to detail
- Adequate computer skills with demonstrated abilities using MS word and excel
- Critical thinker and problem solver
- Friendly, outgoing personality with the ability to 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
- Previous clinical research experience highly desired
- Active RN License in the province of Nova Scotia, Canada.
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.