Health Science Specialist

SUMMARY

The Health Science Specialist supports the conduct of clinical research studies through patient recruitment, screening, enrollment, study coordination, data management, and regulatory compliance. This position works closely with principal investigators, study teams, sponsors, and regulatory personnel to ensure studies are conducted in accordance with approved protocols, Good Clinical Practice (GCP), and applicable regulatory requirements while protecting participant safety and maintaining accurate study documentation.

DUTIES AND RESPONSIBILITIES

• Recruit, screen, enroll, and follow up with eligible study participants in accordance with study protocols and enrollment goals.

• Review study designs and eligibility criteria with investigators and potential participants, and coordinate informed consent procedures in accordance with approved protocols and applicable requirements.

• Monitor study participants throughout their participation, promptly communicate medical concerns to the principal investigator, and support participant safety and confidentiality.

• Collect, enter, review, and maintain accurate study data in case report forms, electronic data capture systems, and other study-specific tools.

• Review source documentation for completeness and accuracy, identify missing or inconsistent data, respond to data queries, and develop study-specific source documentation tools when needed.

• Maintain study documentation, including informed consent forms, regulatory records, participant logs, drug dispensing and device utilization logs, and study-related communications.

• Track and report adverse events, serious adverse events, protocol deviations, waivers, and violations in accordance with study and reporting requirements.

• Coordinate study supplies, including investigational drug and device shipments, and assist with specimen collection, processing, packaging, and shipping as required by study protocols.

• Assist with preparation and maintenance of documents required by regulatory and oversight committees.

• Coordinate study-specific communications and participate in site visits, investigator meetings, conference calls, and Clinical Research Coordinator (CRC) meetings as required.

• Assist with sponsor, VA, FDA, Institutional Review Board (IRB), and other monitoring or auditing activities, including responding to findings and implementing appropriate follow-up actions.

• Provide study coverage and support to other investigators and research projects as needed.

• Practice and adhere to VA Rules of Behavior and applicable requirements for patient confidentiality and research conduct.

• Perform other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES

This position has no supervisory responsibilities.

QUALIFICATIONS

• Bachelor's degree from an accredited four-year college or university, or four years of related experience and/or training, or an equivalent combination of education and experience.

• Proficiency with Microsoft Office applications and the ability to use clinical trial databases and electronic data capture systems.

• Working knowledge of medical and research terminology, human subject protection requirements, and Good Clinical Practice (GCP).

• Strong organizational, prioritization, interpersonal, written, and verbal communication skills.

• Ability to work effectively with a diverse team of healthcare and research professionals.

• Attention to detail and the ability to maintain accurate, complete, and confidential study records.

• Ability to demonstrate proficiency consistent with the Intermediate Clinical Research Coordinator (CRC) level based on ACRP Core competencies.

PREFERRED QUALIFICATIONS

• Clinical research certification, such as ACRP CCRC, CCRA, ACRP-CP, or SOCRA CCRP.

• Experience with specimen or tissue collection, handling, and processing.

• Phlebotomy experience.