Clinical Research Assistant

Job Summary

Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.

Essential Responsibilities and Duties

• Creating and maintaining subject sources for all assigned studies.
• Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate.
• Filing of lab results, EKG results, and other communication in designated source documents.
• Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials.
• Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication.
• Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection.
• Communicating with study participants, caregivers and sponsors as directed.
• Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks.
• Aiding Coordinators in the facilitation of study monitoring visits.
• Completion of duties assigned by CRC as they pertain to the study and/or participants.
• Ensures all study activities are conducted in accordance with GCP, protocol requirements, and site SOPs.
• Maintains confidentiality of subjects information in compliance with HIPAA.
• Ensures accurate, complete, and timely source documentation in subject sources.
• Reports any adverse events or participant concerns to CRC or clinical staff promptly.
• Assumes other duties and responsibilities as assigned.

Minimum Qualifications

• Interest in and knowledge of specific study indications.
• Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).
• Skilled in organization and record maintenance.
• Phlebotomy experience preferred.
• Experience working with subjects.
• Skilled in developing and maintaining effective working relationships with supervisors and co-workers.
• Strong personal initiative and attention to detail.
• Ability to react calmly and effectively in emergency situations.
• Ability to interpret, adapt and apply guidelines and procedures.
• Ability to clearly communicate both orally and verbally.

Physical Requirements

• Ability to sit, stand, and walk for extended periods of time throughout the workday.
• Ability to bend, stoop, kneel, and reach to access supplies, files, and equipment.
• Ability to lift, carry, and move up to 20–25 pounds (e.g., lab kits, study materials, supplies).
• Ability to transport materials between rooms or departments as needed.
• Ability to perform tasks requiring manual dexterity, including handling documents, using computers, and managing study materials and basic clinical equipment.
• Ability to read and interpret written information such as study protocols, subject sources, and lab results.
• Ability to perform accurate data entry and review on a computer for extended periods.
• Ability to communicate effectively with subjects, caregivers, staff, and sponsors.
• Ability to interact with subject in a clinical setting, including escorting participants and assisting with basic assessments as permitted.
• Ability to work in a clinical environment that may involve exposure to medical equipment and bodily fluids while adhering to safety and infection control protocols, including use of PPE if required.
• Ability to maintain focus and accuracy in a fast-paced, detail-oriented environment.
• Ability to manage multiple tasks simultaneously and meet study-related deadlines.