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Clinical Research Associate (CRA)

extra holidays

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's degree in life science/related field, Minimum of 3+ years in clinical research, Solid understanding of GCP and regulatory requirements, Excellent organizational and communication skills, Interpersonal skills to work in a team.

Key responsabilities:

Participate in study protocol review and development
Assist in site selection and qualification process
Conduct training and site initiation visits
Perform monitoring visits and data verification
Communicate regularly with study sites and stakeholders

BioSpace Internet TPE https://www.biospace.com/

11 - 50 Employees

See more BioSpace offers

Job description

Qualifications

Bachelor's degree in life science/related field, advanced degree preferred
Minimum of 3+ years in clinical research industry
Solid understanding of GCP guidelines, regulatory requirements (e.g., EMA, FDA), and clinical trial processes
Excellent organizational, communication, and interpersonal skills.
Ability to manage multiple priorities and work effectively in a team environment

Responsibilities

Participate in study protocol review and development
Assist in site selection and qualification process
Develop study documents such as informed consent forms (ICFs) and study manuals
Conduct site initiation visits (SIVs) to train site staff on study protocols and procedures
Verify site capabilities and ensure availability of necessary study materials
Assist with regulatory document collection and submission
Perform routine monitoring visits to clinical sites according to the monitoring plan
Ensure adherence to the protocol, GCP, and applicable regulatory requirements
Review and verify data accuracy and completeness in source documents and case report forms (CRFs)
Track subject recruitment and enrollment status at clinical sites
Ensure timely resolution of data queries and discrepancies
Monitor investigational product (IP) accountability and storage conditions
Review safety data and ensure proper documentation and reporting
Conduct close-out visits to ensure completeness of study documentation and data
Assist in the resolution of outstanding issues and data queries
Ensure proper archiving of study documents and materials
Maintain regular communication with study sites, investigators, and sponsors
Provide study progress updates and reports to project teams and stakeholders