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
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet Publishing
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