Clinical Research Coordinator II

Care Access•Tampa, FL

1d•$60,000 - $90,000•Onsite

About The Position

The Clinical Research Coordinator II uses Good Clinical Practices (GCP) to screen, enroll, and monitor clinical research participants while ensuring protocol and regulatory compliance. This is a moderate-complexity role involving mixed visit types and active investigational product and adverse-event workflows. The coordinator may operate as the sole CRC onsite, owns studies, prioritizes competing demands, and mentors CRC I peers while providing onboarding and day-to-day guidance. The role coordinates participant visits and study procedures, supports recruitment, maintains accurate study documentation, and works with investigators, site staff, participants, and Sponsor/CRO representatives. It also supports regulatory activities, monitors study quality, and helps ensure supplies and systems are ready for study initiation. The position is onsite with regional commute requirements and up to 10% regional travel, within 100 miles. The expected pay range is $60,000–$90,000 USD per year for full-time team members.

Requirements

At least 3 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 (GCP).
Ability to operate independently for most study activities and escalate complex issues as needed.
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization, and leadership skills, with close attention to detail.
Strong computer skills, including experience with clinical trials databases, IVR systems, electronic data capture, Microsoft Word, and Microsoft Excel.
Critical-thinking and problem-solving ability.
Friendly, outgoing demeanor and 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.
For California-based roles: National phlebotomy certification from an organization approved by the California Department of Public Health.
For Louisiana-based roles: National phlebotomy certification from an organization approved by the Louisiana State Board of Medical Examiners.
For Washington-based roles: National phlebotomy certification from an organization approved by the Washington State Department of Health.
For Nevada-based roles: Laboratory Assistant certification from the Division of Public and Behavioral Health.

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

Prioritize activities with regard to protocol timelines and maintain adherence to FDA regulations and ICH guidelines.
Build effective relationships with study participants and Care Access Research personnel; balance protocol needs with patient experience and proactively address concerns.
Monitor quality metrics, prevent protocol deviations, and resolve queries promptly.
Interact professionally with patients, representatives, investigators, 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.
Mentor CRC I peers and provide onboarding and day-to-day guidance.
Identify adverse events (AEs) and serious adverse events (SAEs) and promptly notify the Principal Investigator and Sponsor where appropriate.
Prescreen study candidates and obtain informed consent in accordance with Care Access Research 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, procedures, eligibility criteria, and impacts on office flow with the Investigator and site staff.
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-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 and developing recruitment plans; obtain lists of potential candidates from subject databases.
Work with the recruitment team to contact and recruit study participants.
Review protocols and amendments for clarity and logistical feasibility.
Communicate clearly, anticipate needs, propose solutions, and manage change effectively.
Attend Investigator meetings.
Ensure supplies and resources are available for protocol initiation, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Manage stakeholder communications and facilitate visits and meetings.