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Key Responsibilities and Required Skills for Vaccine Research Coordinator

💰 $55,000 - $85,000

HealthcareResearchClinical TrialsPharmaceuticalsBiotechnology

🎯 Role Definition

Are you passionate about being at the forefront of medical innovation and public health? This role requires a highly organized and dedicated Vaccine Research Coordinator to join a dynamic clinical research team. In this pivotal role, you will be the backbone of groundbreaking vaccine trials, ensuring they are conducted with the highest standards of safety, ethics, and data integrity. You'll serve as the primary link between principal investigators, study sponsors, regulatory bodies, and, most importantly, the volunteer participants who make this research possible. If you thrive in a fast-paced environment and are driven by the mission to prevent infectious diseases, this is your opportunity to make a tangible impact on global health.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Assistant
  • Registered Nurse (RN) or Licensed Practical Nurse (LPN)
  • Medical Assistant with research experience
  • Public Health Professional or recent graduate (MPH, MS)

Advancement To:

  • Senior Clinical Research Coordinator / Lead Coordinator
  • Clinical Trial Manager
  • Clinical Research Project Manager
  • Regulatory Affairs Manager

Lateral Moves:

  • Clinical Data Coordinator / Manager
  • Clinical Quality Assurance Specialist
  • Medical Science Liaison (entry-level)

Core Responsibilities

Primary Functions

  • Manage the complete lifecycle of multiple vaccine clinical trials, from study start-up and patient recruitment through to study close-out.
  • Screen, recruit, and obtain informed consent from eligible study participants, ensuring they fully understand trial procedures, risks, and benefits.
  • Coordinate and conduct all study-related visits and procedures according to the clinical protocol, including vital signs, physical assessments, and questionnaires.
  • Administer investigational vaccines, agents, and placebos accurately and safely as dictated by the protocol and under the supervision of the Principal Investigator.
  • Perform and/or coordinate phlebotomy, as well as the collection, processing, logging, and shipment of biological specimens (e.g., blood, nasal swabs) to central laboratories.
  • Maintain meticulous, accurate, and up-to-date source documentation for all study activities, both on paper and in electronic health record (EHR) systems.
  • Complete Case Report Forms (CRFs) and enter study data into Electronic Data Capture (EDC) systems with a high degree of accuracy and within sponsor-defined timelines.
  • Proactively identify, document, and report adverse events (AEs) and serious adverse events (SAEs) to the Principal Investigator, sponsor, and IRB in accordance with regulatory requirements.
  • Ensure strict adherence to study protocols, Good Clinical Practice (GCP) guidelines, and all applicable FDA, IRB, and institutional regulations.
  • Manage the accountability, storage, temperature monitoring, and dispensation of investigational products (vaccines/drugs) and study supplies.
  • Serve as the primary point of contact for study participants, addressing their questions, scheduling visits, and ensuring their retention and compliance throughout the trial.
  • Prepare for and actively participate in site initiation visits (SIV), interim monitoring visits (IMV), quality assurance audits, and close-out visits (COV).
  • Resolve data queries generated by sponsors, Contract Research Organizations (CROs), or data management teams in a timely manner.
  • Communicate effectively with the Principal Investigator, sub-investigators, sponsors, CROs, and monitors regarding study progress, challenges, and participant status.
  • Develop and implement effective patient recruitment and retention strategies, including creating flyers, outreach materials, and managing recruitment databases.

Secondary Functions

  • Assist the Principal Investigator and regulatory team with the preparation, submission, and maintenance of all regulatory documents for the Institutional Review Board (IRB), including initial submissions, amendments, and annual renewals.
  • Maintain organized and audit-ready regulatory binders and participant study binders.
  • Contribute to the assessment of clinical trial feasibility by reviewing new protocols and providing operational input.
  • Train and mentor junior staff, students, or new coordinators on study-specific procedures and general clinical research conduct.
  • Manage and track study-related expenses, patient stipend payments, and invoices to ensure budgetary compliance.
  • Perform regular quality control checks on source documents, eCRF data, and other study-related records to ensure data integrity.
  • Participate in team meetings, investigator meetings, and ongoing protocol-specific training to stay current with all study requirements and amendments.

Required Skills & Competencies

Hard Skills (Technical)

  • GCP & Regulatory Knowledge: Deep understanding of Good Clinical Practice (GCP), FDA regulations (21 CFR), and HIPAA, with proven experience in applying these principles in a clinical trial setting.
  • EDC Systems: Proficiency in using Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, or Inform.
  • Clinical Procedures: Certification and/or hands-on experience in phlebotomy, processing biological specimens, and administering injections/vaccines.
  • IRB Submissions: Experience preparing and managing submissions to an Institutional Review Board (IRB).
  • Clinical Trial Management Systems (CTMS): Familiarity with CTMS software for tracking trial milestones, enrollment, and finances.
  • Microsoft Office Suite: Advanced proficiency in Word, Excel, and Outlook for documentation, tracking, and communication.
  • Medical Terminology: Comprehensive knowledge of medical terminology, particularly related to immunology and infectious diseases.

Soft Skills

  • Attention to Detail: Exceptional meticulousness and accuracy in data collection, documentation, and following complex protocols.
  • Interpersonal & Patient-Facing Skills: Outstanding communication skills with the ability to build rapport, trust, and empathy with a diverse patient population.
  • Organizational & Time Management: Superior ability to manage and prioritize multiple complex tasks, protocols, and deadlines simultaneously in a fast-paced environment.
  • Critical Thinking & Problem-Solving: Proactive in identifying potential issues, troubleshooting problems, and implementing effective solutions with sound judgment.
  • Collaboration & Teamwork: Ability to work effectively within a multidisciplinary team, including physicians, nurses, lab staff, and administrators.
  • Autonomy & Initiative: A self-starter who can work independently with minimal supervision while understanding when to escalate issues.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree in a relevant scientific or health-related field. An Associate's Degree or Nursing Diploma combined with significant, directly relevant experience may be considered.

Preferred Education:

  • Master of Public Health (MPH)
  • Master of Science (MS) in Clinical Research or a related Life Science
  • Bachelor of Science in Nursing (BSN)

Relevant Fields of Study:

  • Life Sciences (Biology, Microbiology, Immunology)
  • Nursing
  • Public Health
  • Health Sciences

Experience Requirements

Typical Experience Range:

2-5 years of direct experience as a Clinical Research Coordinator in an academic, pharmaceutical, or CRO setting.

Preferred:

  • At least 1-2 years of experience specifically coordinating vaccine or infectious disease clinical trials.
  • Certification as a Clinical Research Coordinator (CCRC) from ACRP or a Clinical Research Professional (CCRP) from SoCRA is highly desirable.
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