Clinical Research Coordinator I

ALLIANCE CLINICAL LLC•City of North Tonawanda, NY

3d•$24 - $30

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 support adherence to Good Clinical Practice (GCP) guidelines. The CRC communicates with participants, administers questionnaires, collects and documents medical information, obtains informed consent, tracks investigational product accountability and storage temperatures, coordinates laboratory testing, and conducts protocol-specific clinical procedures. The role also includes maintaining regulatory and study records, verifying and entering data, managing study startup documentation and timelines, supporting recruitment and monitoring visits, and resolving data queries. The CRC must maintain confidentiality and meet protocol requirements and deadlines. Alliance Clinical Network advances medical research by enrolling diverse populations in high-quality clinical trials. The company emphasizes integrity, excellence, respectful and compassionate participant care, and a supportive, collaborative environment. ACN does not provide visa sponsorship; candidates who require immigration or visa sponsorship now or in the future are not eligible.

Requirements

At least 2 years of experience with phlebotomy and EKG procedures.
Current Certified Phlebotomy Technician (CPT) license.
Associate’s degree in healthcare or a related field, or equivalent relevant experience.
At least 2 years of experience in a healthcare setting.
At least 2 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 who require immigration or visa sponsorship now or in the future are not eligible; ACN does not provide visa sponsorship.

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 participant medical histories 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 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.