Clinical Research Coordinator I

ALLIANCE CLINICAL LLC•Houston, TX

About The Position

The Clinical Research Coordinator I (CRC) supports clinical trials by coordinating study visits, managing data collection, and ensuring compliance with study protocols and regulatory guidelines. The role includes direct interaction with participants and monitoring their health throughout the trial. The CRC helps maintain study integrity and quality and collaborates with the Principal Investigator (PI) to oversee studies and ensure adherence to Good Clinical Practice (GCP). The CRC communicates study objectives and instructions to participants, administers questionnaires, monitors protocol compliance, collects health and medication information, obtains informed consent, and responds to participant needs. The position also involves maintaining accurate investigational product records and storage temperatures, coordinating laboratory testing, reviewing medical records and lab reports, conducting and documenting clinical assessments and procedures, maintaining regulatory files, verifying study data, developing electronic source documents, supporting recruitment, and managing startup documentation, training, and timelines. The CRC enters data into electronic data capture systems, resolves queries, and assists with monitoring visits. Alliance Clinical Network states that it does not provide visa sponsorship. Candidates who require immigration or visa sponsorship now or in the future, including H-1B, TN, or STEM OPT training plans, are not eligible.

Requirements

Two years of experience with phlebotomy and EKG procedures.
An associate’s degree in healthcare or a related field, or equivalent relevant experience.
At least two years of experience in a healthcare setting.
At least two years of experience with FDA regulations and Good Clinical Practice (GCP).
Demonstrated analytical reasoning skills.
Exceptional attention to detail and strong organizational skills.
Excellent verbal and written communication abilities.
Proven customer service skills with internal and external stakeholders.
Ability to effectively manage multiple priorities in a fast-paced environment.
Candidates requiring immigration or visa sponsorship now or at any time in the future are not eligible; the company does not provide visa sponsorship.

Nice To Haves

Current Certified Phlebotomy Technician (CPT) license.

Responsibilities

Communicate clearly and professionally with study participants about study objectives and ongoing instructions.
Adhere to site standard operating procedures (SOPs).
Administer questionnaires and monitor participant compliance with study protocols.
Respond promptly and appropriately to participant needs.
Collect and document patient medical history and health conditions.
Obtain and document informed consent from study participants.
Maintain accurate records of investigational product (IP) dispensation and accountability.
Coordinate with laboratories to ensure timely testing and reporting.
Collect and document information on concomitant medications.
Review medical records for protocol compliance.
Perform and document assessments for adverse events (AEs) and serious adverse events (SAEs).
Conduct clinical procedures including EKGs, vital signs, nasal swabs, and other protocol-specific tasks.
Review clinical laboratory reports in accordance with protocol requirements.
Maintain up-to-date regulatory files for the research site.
Verify the accuracy and completeness of collected data.
Monitor and document temperatures for IP storage.
Support recruitment and engagement of study participants as needed.
Develop electronic source (eSource) documents in accordance with study protocols.
Manage study startup documentation, training, and timelines for assigned protocols.
Ensure all protocol requirements and deadlines are met consistently.
Maintain strict confidentiality and compliance with regulatory standards.
Assist with preparation for monitoring visits.
Enter data into electronic data capture (EDC) systems and resolve data queries.
Perform other duties as assigned.