Clinical Research Coordinator III

Care Access•Dalton, GA

3d•Onsite

About The Position

The Clinical Research Coordinator III uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical research study participants while ensuring protocol and regulatory compliance. This role leads the most pivotal and complex protocols and study designs at Care Access Research sites, including high-complexity studies with intensive assessments, multiple arms, and frequent sponsor interaction. The coordinator balances protocol requirements with participant experience and safety, may operate as the sole CRC onsite, and serves as a primary point of contact for the site and key sponsors and CROs. The role coordinates participant visits and clinical procedures, manages study documentation and recruitment activities, and supports site operations, quality, and compliance. It also mentors and trains CRAs and CRC I/CRC II staff, supports process improvements, leads complex studies, and represents the site with sponsors and CROs. The position is onsite and includes regional commuting requirements and up to 10% travel. Physical demands include using keyboards and other computer equipment; walking, standing, sitting, lifting up to and over 25 pounds, including overhead lifting; and driving approximately 20% of the time.

Requirements

At least 5 years of prior Clinical Research Coordinator experience.
Recent phlebotomy experience.
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology.
Excellent working knowledge of federal regulations and Good Clinical Practice (GCP).
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization, and leadership skills, with strong attention to detail.
Strong computer skills, including demonstrated ability with clinical trials databases, IVR systems, electronic data capture, Microsoft Word, and Excel.
Critical-thinking and problem-solving ability.
Friendly, outgoing personality and ability to maintain a positive attitude under pressure.
High self-motivation and energy.
Excellent professional writing and communication skills.
Ability to work independently in a fast-paced environment with minimal supervision.
Ability to engage in continuous independent learning within the therapeutic area of responsibility.
Ability to lead study execution autonomously and resolve operational challenges independently.
Ability to use keyboards and other computer equipment; ability to walk, stand, sit, lift up to and over 25 pounds including overhead, and drive.

Nice To Haves

Bachelor’s degree preferred, or equivalent combination of education, training, and experience.
One year of experience as a Care Access Research Clinical Research Coordinator preferred.

Responsibilities

Manage complex therapeutic areas and study designs, including high-complexity studies with intensive assessments, multiple arms, and frequent sponsor interaction.
Balance protocol requirements with participant experience and safety, and model best practices across studies.
Prescreen study candidates and obtain informed consent according to Care Access SOPs.
Complete protocol-required visit procedures and basic clinical procedures, including blood draws, vital signs, and ECGs.
Review laboratory, ECG, and other test results for completeness and alert values, and ensure timely investigator review.
Discuss study medication, required procedures, eligibility criteria, and effects on office workflow with the Investigator and site staff.
Prioritize activities according to protocol timelines and maintain adherence to FDA regulations and ICH guidelines.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events and serious adverse events, and promptly notify the Principal Investigator and Sponsor when appropriate.
Record data legibly and enter it in real time in paper or electronic source documents.
Accurately record study medication inventory, dispensation, and participant compliance.
Resolve data management queries and correct source data within sponsor-provided timelines.
Assist regulatory personnel with completing and filing regulatory documents, and assist in creating and reviewing source documents.
Assist with planning and creating recruitment materials, developing recruitment plans, obtaining candidate lists from the subject database, and calling and recruiting participants with the recruitment team.
Serve as the primary point of contact for the site and support key Sponsors and CROs.
Mentor and train CRAs and CRC I/CRC II staff on Care Access processes, SOPs, and values, supporting their transition to more demanding opportunities and responsibilities.
Support training and process improvements.
Assist the Regional Site Director, Operational Compliance, and Quality Assurance Departments with Care Quality and FDA audits.
Develop and maintain CAPAs when needed, with approval from the Regional Site Director.
Review and assess protocols and amendments for clarity and logistical feasibility; set quality standards, prepare for audits, and lead corrective actions.
Ensure all training and study requirements are met before trial conduct.
Communicate clearly verbally and in writing, and attend Investigator meetings as required.
Ensure adequate supplies and access are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Maintain positive professional relationships with patients, sponsor representatives, investigators, and Care Access Research personnel and management.
Maintain deep therapeutic-area knowledge, including understanding related protocol designs, outcomes, and timelines.
Drive improvements, remove barriers, mentor others through change, lead cross-site communications, and independently resolve operational challenges.