Assistant Clinical Research Coordinator (Temporary)

udy protocols, regulatory guidelines, and Good Clinical Practice (GCP). This position is ideal for individuals looking to grow their career in clinical research and contribute to advancing medical science.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Assist in screening and recruiting study participants according to protocol eligibility criteria.
• Schedule and coordinate participant visits, including study procedures, assessments, and follow-ups.
• Collect and record study data accurately in case report forms (CRFs) and electronic data capture (EDC) systems.
• Maintain study documentation, including source documents, regulatory files, and participant records.
• Support informed consent discussions by ensuring participants understand study requirements.
• Assist in monitoring participants for adverse events and report findings to the CRC or Principal Investigator (PI).
• Coordinate specimen collection, processing, and shipment per protocol requirements.
• Ensure compliance with study protocols, institutional policies, and regulatory requirements (FDA, IRB, ICH-GCP).
• Prepare study materials, including study kits, lab supplies, and regulatory binders.
• Communicate effectively with investigators, study sponsors, monitors, and other research staff.
• Perform administrative duties related to research studies, such as data entry, filing, and appointment reminders.
• Draw labs from study participants as required by protocol.
• Process laboratory samples, including centrifugation, aliquoting, and storage per protocol specifications.
• Ship biological samples following regulatory guidelines and sponsor instructions.
• Manage and maintain study inventory, including lab kits, investigational products, and other clinical supplies.

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPREIENCE:
• Associate degree in a health-related field (e.g., Biology, Nursing, Public Health, or related discipline) preferred. Equivalent experience may be considered.
• Certified Phlebotomy Technician (CPT) certification required.
• Prior experience in healthcare, research, or clinical settings is a plus but not required.
• Basic knowledge of clinical research processes and regulations (GCP, FDA, IRB) is a plus.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills to interact with patients, staff, and external stakeholders.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook) and ability to learn electronic data capture systems.