Clinical Research Coordinator Jobs

About The Position

Requirements

• 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.
• Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
• A minimum of 3 years prior Clinical Research Coordinator experience required
• Recent phlebotomy experience required
• California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
• Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
• Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
• Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health

Nice To Haves

• Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator

Responsibilities

• 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.
• Monitors quality metrics; prevents deviations; resolves queries quickly.
• Interact in a positive, professional manner with patients, .representatives, investigators and Care Access Research personnel and management.
• Coordinate and attend 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.
• Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
• Moderate complexity; mixed visit types, active IP and AE/SAE workflows.
• Can operate as solo CRC onsite.
• Prescreen study candidates
• Obtain informed consent per Care Access Research SOP .
• Complete visit procedures in accordance with protocol.
• 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.
• Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
• Record data legibly and enter in real time on paper or e-source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance.
• Resolve data management queries and correct source data within sponsor provided timelines
• Assist regulatory personnel with completion and filing of regulatory documents.
• Assist in the creation and review of source documents.
• 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
• Review and assess protocol (including amendments) for clarity, logistical feasibility
• Ensure that all training and study requirements are met prior to trial conduct.
• Communicate clearly verbally and in writing.
• Anticipates needs; proposes solutions; manages change effectively.
• Attend Investigator meetings as required.
• Owns studies; prioritizes competing demands; mentors CRC I.
• Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

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