Responsibilities:

• As a vital member of our clinical team, the Clinical Research Associate will be responsible for conducting Phase I-IV single or multi-center studies in adherence to Federal Regulations and ICH guidelines.

Key responsibilities include:

• Collaborating with senior staff in planning study conduct.
• Designing case report forms (CRFs) and managing Contract Research.
• Organization (CRO) selection.
• Selecting and training investigator sites, planning and organizing study meetings.
• Evaluating, selecting, and training new study investigators.
• Writing and assembling submissions related to study protocols.
• Monitoring investigational sites to ensure protocol adherence.
• Ensuring timely enrollment of patients and retrieval of CRFs from study sites.
• Processing CRFs, including data cleanup and classification of data.
• Completing study summaries and reports.

Experience:

• The ideal candidate should possess a minimum of 2 years of experience in clinical research monitoring.

Key qualifications include:

• Proven experience in the successful execution and monitoring of clinical trials.
• Familiarity with Federal Regulations and ICH guidelines.
• Strong attention to detail and organizational skills.
• Ability to work effectively within a collaborative team environment.
• Experience with vaccines against infectious diseases clinical trials highly desired but not absolutely necessary.

Education:

• A minimum of an Associate degree is required, but preference will be given to candidates with a Bachelor's degree.
• Additionally, candidates should have at least 2 years of monitoring experience with preference on vaccines against infectious diseases clinical trials.