Clinical Research Coordinator III

Care Access•Houston, TX

21h•$65,000 - $95,000•Onsite

About The Position

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. The CRC III is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites.

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)
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
Ability to work independently in a fast-paced environment with minimal supervision.
Engage in continuous independent learning within the therapeutic area of responsibility
Leads cross‑site communications; represents site with sponsors/CROs.
Highly autonomous; leads study execution and resolves operational challenges independent
Bachelor’s Degree preferred, or equivalent combination of education, training and experience.
A minimum of 5 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

Patient Coordination
Manages some of the sites most challenging therapeutic areas and study designs
High complexity; intensive assessments, multi‑arm trials, frequent sponsor interaction.
Champions balancing protocol needs with patient experience and safety across studies; models best practices.
Can operate as solo CRC onsite
Prescreen study candidates
Obtain informed consent per Care Access SOP
Complete visit procedures in accordance with protocol.
Complete basic clinical procedures per protocol, 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.
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
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.
Patient Recruitment
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
Site Support
Primary point of contact for the site
Supports Key Sponsors and CROs
Responsible for mentoring and training CRAs and CRC I/CRC II to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
Supports training and process improvements.
Assist Regional Site Director, Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits
Develops and maintains CAPAs, when needed, with approvals from the Regional Site Director
Review and assess protocol (including amendments) for clarity, logistical feasibility
Sets quality standards; prepares for audits; leads corrective actions.
Other Responsibilities
Leads complex studies; coaches team; influences site operations.
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Attend Investigator meetings as required.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
Maintain effective relationships with study participants and other care Access Research personnel.
Demonstrate deep knowledge about the therapeutic area of responsibility including comprehensive understanding of related Protocol designs, outcomes and timelines
Drives improvements; removes barriers; mentors others through change.