Regional Travel, Clinical Research Coordinator

About the role

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.

Responsibilities

• Patient Coordination
• Prioritize activities with specific regard to protocol timelines
• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
• Maintain effective relationships with study participants and other Care Access Research personnel.
• Balances protocol needs with patient experience; proactively addresses concerns.
• Maintains quality metrics; prevents deviations; resolves queries quickly.
• Interacts in a positive, professional manner with patients, representatives, investigators, and Care Access Research personnel and management.
• Coordinates and attends pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
• Mentors CRC I peers; provides onboarding and day-to-day guidance.
• Identifies adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notifies Principal Investigator and Sponsor (where appropriate)
• Moderate complexity; mixed visit types, active IP and AE/SAE workflows.
• Can operate as solo CRC onsite.
• Prescreens study candidates
• Obtains informed consent per Care Access Research SOP
• Completes visit procedures in accordance with protocol.
• Completes basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
• Reviews laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
• Discusses study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
• Documentation
• Records data legibly and enters in real time on paper or e-source documents
• Accurately records study medication inventory, medication dispensation, and patient compliance.
• Resolves data management queries and corrects source data within sponsor provided timelines
• Assists regulatory personnel with completion and filing of regulatory documents.
• Assists in the creation and review of source documents.
• Patient Recruitment
• Assists with planning and creation of appropriate recruitment materials.
• Assists in developing recruitment plan and obtains listing of potential candidates to contact from subject database.
• Actively works with recruitment team in calling and recruiting subjects.
• Other Responsibilities
• Reviews and assesses protocol (including amendments) for clarity, logistical feasibility
• Ensures that all training and study requirements are met prior to trial conduct.
• Communicates clearly verbally and in writing.
• Anticipates needs; proposes solutions; manages change effectively.
• Attends Investigator meetings as required.
• Owns studies; prioritizes competing demands; mentors CRC I.
• Ensures adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords).

Requirements

• Minimum Education: Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• Minimum Experience: A minimum of 3 years prior Clinical Research Coordinator experience required
• Preferred Experience: 1 year of experience as a Care Access Research Clinical Research Coordinator
• Recent Phlebotomy Experience Required
• Location: Onsite daily at local site within our Southeast region. Locations include Decatur, GA, Raleigh, NC, and Fayetteville, NC. Travel within the region to other locations for support as needed.
• Travel: This role requires up to 75% travel. Length of travel will depend upon study requirements, site needs, and company initiatives.
• Physical Demands: The ability to use keyboards and other computer equipment.

Expertise Required

• Ability to understand and follow institutional SOPs.
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Operates independently for most study activities; escalates complex issues as needed.
• 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.
• 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
• Manages stakeholder communications; facilitates visits and meetings.
• Ability to work independently in a fast-paced environment with minimal supervision.

The Expertise Required

• Ability to understand and follow institutional SOPs.
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Operates independently for most study activities; escalates complex issues as needed.
• 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.
• 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
• Manages stakeholder communications; facilitates visits and meetings.
• Ability to work independently in a fast-paced environment with minimal supervision.

Qualifications

• Minimum Education: Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• Minimum Experience: A minimum of 3 years prior Clinical Research Coordinator experience required
• Preferred Experience: 1 year of experience as a Care Access Research Clinical Research Coordinator
• Recent Phlebotomy Experience Required

Skills

• Ability to understand and follow institutional SOPs.
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Operates independently for most study activities; escalates complex issues as needed.
• 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.
• 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
• Manages stakeholder communications; facilitates visits and meetings.
• Ability to work independently in a fast-paced environment with minimal supervision.

Benefits & Perks

• 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