Vaccines Clinical Trials Coordinator

2 weeks ago

Oceanside, California, United States Profound Research Full time
Job OverviewPurpose of the Position


The Vaccines Clinical Trials Coordinator is responsible for overseeing all aspects of clinical trial operations while ensuring adherence to all relevant laws, regulations, and study protocols, in alignment with the mission and values of Profound Research.

Key Responsibilities

  • Oversee and execute all clinical trial operations in line with established research protocols and standards, ensuring compliance with applicable laws, regulations, and organizational policies.
  • Complete all necessary training provided by Profound Research, including ICH-GCP and IATA certifications, in a timely manner.
  • Provide mentorship and training to team members on clinical trial execution, protocol adherence, and effective trial management.
  • Lead and coordinate tasks for assigned clinical trials, including but not limited to study initiation, vendor oversight, participant recruitment, source document review, protocol education, collection of regulatory documentation, participant engagement, timely data collection and documentation, management of adverse events, and monitoring visits.
  • Ensure that all team members apply good documentation practices when collecting, maintaining, and correcting study data and records, including source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
  • Maintain effective and professional communication with colleagues, leadership, study participants, sponsors, CROs, and vendors.
  • Manage and account for supplies provided by sponsors, including lab kits, ancillary supplies, and investigational products.
  • Perform additional responsibilities as assigned.
Qualifications

- Preferred experience in coordinating Vaccine Trials

  • Bachelor's degree with 2 years of relevant experience in the life sciences field OR
  • Associate's degree with 4 years of relevant experience in the life sciences field OR
  • High School diploma or technical degree with a minimum of 6 years of relevant experience in the life sciences field AND 1 year of
  • Clinical Research Coordinator experience.
  • Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of starting the role.
  • Experience in conducting clinical assessments, including obtaining vital signs, EKGs, blood draws, and processing/shipping lab specimens.
  • Demonstrated ability to work independently, effectively plan, and prioritize tasks with minimal supervision.
  • Strong attention to detail, organizational skills, and effective communication with diverse stakeholders.
  • Ability to collaborate as a team player and adapt to changing schedules and responsibilities.
Travel Expectations

Regular travel to clinical sites may be required.

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