Clinical Research Coordinator II

Care Access•Tampa, FL

2d•$60,000 - $90,000•Onsite

About The Position

The Clinical Research Coordinator II uses Good Clinical Practices (GCP) to screen, enroll, and closely monitor clinical research study subjects while ensuring protocol and regulatory compliance. The role supports moderately complex studies with mixed visit types and active investigational product and adverse event workflows, and may operate as the sole CRC onsite. The coordinator owns studies, balances protocol requirements with patient experience, and provides mentoring and day-to-day guidance to CRC I peers. The position coordinates participant visits and clinical procedures, maintains accurate study documentation and medication records, resolves data queries, supports regulatory documentation, and contributes to participant recruitment. It also coordinates with investigators, site staff, participants, Care Access personnel, and Sponsor/CRO representatives. The role is onsite with regional commute requirements and requires up to 10% regional travel within 100 miles, depending on study requirements, staffing needs, and company initiatives.

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 when needed.
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 skills.
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.
Ability to use keyboards and other computer equipment.
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, or equivalent combination of education, training, and experience.
One year of experience as a Care Access Research Clinical Research Coordinator.

Responsibilities

Prioritize activities according to protocol timelines and maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs.
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 when appropriate.
Prescreen study candidates and obtain informed consent in accordance with Care Access Research SOPs.
Complete protocol-required visit procedures and basic clinical procedures such as 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 flow with the Investigator and site staff.
Record study data legibly and in real time on paper or e-source documents.
Accurately document study medication inventory, medication 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 actively with the recruitment team to call and recruit subjects.
Review protocols, including amendments, for clarity and logistical feasibility.
Communicate clearly verbally and in writing; anticipate needs, propose solutions, and manage change effectively.
Attend Investigator meetings as required and manage studies while prioritizing competing demands.
Ensure supplies needed for protocol initiation are onsite, including lab kits, study medication, specialized equipment, and IVRS/EDC access and passwords.
Facilitate stakeholder communications, visits, and meetings.