General Summary

We are seeking a highly organized, detail-oriented Study Coordinator to join our clinical trials site team. In this role, you will manage the daily operations of an upcoming phase III clinical trial for an investigational vaccine. You will serve as the primary operational link between study participants, the Principal Investigator (PI), the study team, and the sponsor. The ideal candidate has strong clinical trial experience, a thorough understanding of Good Clinical Practice (GCP), and a solid baseline background in managing complex handling protocols for biological or temperature-sensitive assets.

Key Responsibilities

• Participant Recruitment & Enrollment: Screen electronic medical records to identify potentially eligible trial participants based on strict inclusion/exclusion criteria. Coordinate pre-screening outreach and manage high-volume scheduling for multiple patient cohorts.
• Informed Consent Support: Assist the Investigators during the informed consent process, ensuring all participants comprehensively understand the trial milestones, risks, benefits, and safety requirements.
• Study Visit Coordination: Schedule and execute participant visits strictly according to the protocol timeline (e.g., baseline, dosing day, and follow-up).
• Data Collection & Management: Accurately document all participant data in Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Query and resolve data discrepancies in a timely manner to maintain sponsor data integrity deadlines.
• Investigational Product (IP) Logistical Oversight: Collaborate with the research pharmacy to ensure proper handling, tracking, and compliance of the temperature-sensitive vaccine candidate (e.g., cold chain storage requirements).
• Specimen Logistics Coordination: Oversee the exact collection, labeling, processing (e.g., aliquoting serum/plasma via manual or automated instruments), and rapid domestic/international shipping of biospecimens.
• Safety Reporting Compliance: Monitor participants for post-injection reactions, local reactogenicity, and unexpected changes in health status. Immediately track, log, and escalate Adverse Events (AEs) and Serious Adverse Events (SAEs) to the PI, internal medical monitors, and sponsor safety teams.
• Regulatory & Audit Preparation: Maintain an immaculate, audit-ready Investigator Site File (ISF). Prepare for routine monitoring visits conducted by the sponsor’s Clinical Research Associates (CRAs)

Academic Qualifications

Bachelor’s degree in Medicine, Nursing, Public Health, Healthcare Administration, or an equivalent health-related discipline.

Person Specification

• Education: Bachelor’s degree in Medicine, Nursing, Public Health, Healthcare Administration, or an equivalent health-related discipline.
• Experience: Minimum of 2–3 years of Clinical trial coordination experience, ideally with previous exposure to managing vaccine, immunology, or infectious disease protocols.
• Certifications: Active Good Clinical Practice and responsible conduct of research and Human Subjects Protection
• Technical Skills: Proficiency with Electronic Data Capture software (e.g., Medidata Rave, Oracle Clinical) and Electronic Medical Records (EMR) systems (e.g., Epic, Cerner).
• Direct hands-on experience handling cold-chain biological logistics or managing interactive e-diaries (used by vaccine trial participants to log daily symptoms).

Core Competencies

• Attention to Detail: Absolute precision in capturing vitals, medication changes, and lab processing steps where small deviations compromise study data validity.
• Communication: Exceptional interpersonal skills tailored for communicating complex medical study components clearly to diverse participant groups.
• Time Management: Ability to manage rapidly shifting priorities across large patient cohorts while adhering strictly to time-sensitive protocol window requirements.

• Screen electronic medical records to identify potentially eligible trial participants based on strict inclusion/exclusion criteria; coordinate pre-screening outreach and manage high-volume scheduling for multiple patient cohorts.
• Assist the Investigators during the informed consent process, ensuring all participants comprehensively understand the trial milestones, risks, benefits, and safety requirements.
• Schedule and execute participant visits strictly according to the protocol timeline.
• Accurately document participant data in Electronic Data Capture systems and Case Report Forms; query and resolve data discrepancies in a timely manner.
• Collaborate with the research pharmacy to ensure proper handling, tracking, and compliance of the temperature-sensitive vaccine candidate.
• Oversee collection, labeling, processing, and rapid domestic/international shipping of biospecimens.
• Monitor participants for post-injection reactions, local reactogenicity, and unexpected changes in health status; track, log, and escalate AEs and SAEs.
• Maintain an audit-ready Investigator Site File and prepare for routine sponsor monitoring visits.

• Good Clinical Practice (GCP)
• Clinical trial coordination
• Electronic Data Capture software, including Medidata Rave or Oracle Clinical
• Electronic Medical Records systems, including Epic or Cerner
• Cold-chain biological logistics
• Interactive e-diary management
• Specimen collection, labeling, processing, and shipping
• Adverse Event and Serious Adverse Event reporting
• Attention to detail
• Communication
• Time management

• Bachelor’s degree in Medicine, Nursing, Public Health, Healthcare Administration, or an equivalent health-related discipline.
• Active Good Clinical Practice certification.
• Responsible conduct of research and Human Subjects Protection certification.
• Direct hands-on experience handling cold-chain biological logistics or managing interactive e-diaries.