Clinical Research Coordinator III

Care Access•Dalton, GA

3d•$65,000 - $95,000•Onsite

About The Position

The Clinical Research Coordinator (CRC III) uses Good Clinical Practices to screen, enroll, and closely monitor clinical research participants while ensuring protocol and regulatory compliance. The role is responsible for the most pivotal and complex protocols and study designs at Care Access Research sites, including high-complexity studies with intensive assessments, multi-arm trials, and frequent sponsor interaction. The coordinator balances protocol requirements with participant experience and safety, models best practices, and may operate as the sole CRC onsite. The position coordinates study visits and procedures, reviews test results, supports recruitment and regulatory documentation, and maintains accurate study records. It serves as a primary site contact, supports sponsors and CROs, mentors and trains other staff, contributes to quality and process improvements, and helps prepare for audits. This is an onsite position with regional commute requirements and up to 10% travel.

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, federal regulations, and Good Clinical Practices.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization, and leadership capabilities, with 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 assigned therapeutic area.
High autonomy in leading study execution and independently resolving operational challenges.
Ability to use keyboards and other computer equipment; walk, stand, sit, lift up to and over 25 pounds, lift overhead, and drive.

Nice To Haves

Bachelor’s degree preferred, or an 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 studies with intensive assessments, multi-arm trials, and frequent sponsor interaction.
Balance protocol requirements with participant experience and safety, model best practices, and operate independently onsite when needed.
Prescreen study candidates and obtain informed consent in accordance with Care Access SOPs.
Complete protocol-required visit procedures and basic clinical procedures such as blood draws, vital signs, and ECGs.
Review laboratory, ECG, MRI, and other test results for completeness and alert values, and ensure timely investigator review.
Discuss study medication, 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 study data legibly and in real time on paper or e-source documents.
Accurately record study medication inventory, dispensation, and participant compliance.
Resolve data management queries and correct source data within sponsor timelines.
Assist regulatory personnel with completing and filing regulatory documents, and assist with creating and reviewing source documents.
Assist with planning and creating recruitment materials, developing recruitment plans, identifying potential candidates from subject databases, and contacting and recruiting participants.
Serve as the primary site contact and support key sponsors and CROs.
Mentor and train CRAs and CRC I/CRC II staff on Care Access processes, SOPs, and values.
Support training and process improvements, and 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 protocols and amendments for clarity and logistical feasibility; set quality standards, prepare for audits, and lead corrective actions.
Lead complex studies, coach team members, influence site operations, drive improvements, remove barriers, and mentor others through change.
Ensure training and study requirements are met before trial conduct.
Communicate clearly in writing and verbally, attend Investigator meetings as required, and maintain positive professional relationships with participants, sponsors, investigators, colleagues, and management.
Ensure required supplies and access are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Maintain deep knowledge of the assigned therapeutic area, related protocol designs, outcomes, and timelines; lead cross-site communications and represent the site with sponsors and CROs.