Job Summary
The Contract Clinical Research Associate (CRA) plays a vital role in the successful execution of clinical trials. This position is responsible for monitoring clinical sites to ensure compliance with regulatory standards and study protocols. The CRA serves as a crucial link between the sponsor and the sites, facilitating communication and ensuring that quality data is collected efficiently.
Responsibilities
- Oversee and manage the performance of clinical trial sites to guarantee adherence to study protocols and regulatory requirements.
- Conduct regular site visits and provide training and guidance to site staff on study procedures.
- Ensure the accuracy and completeness of collected data through diligent source document verification and monitoring activities.
- Collaborate with various stakeholders, including investigators and other clinical personnel, to ensure smooth project execution.
- Document and report any investigator/site issues or deviations in compliance with company policies.
- Assist in the preparation and tracking of study materials, including regulatory submissions and reports.
Qualifications
- A bachelor’s degree in life sciences or a related field.
- Previous experience in clinical research or a related discipline, particularly as a CRA.
- Strong understanding of Good Clinical Practice (GCP) and regulatory framework.
- Excellent communication and interpersonal skills, capable of building relationships with diverse stakeholders.
- Proficiency in project management and organizational skills to manage multiple tasks effectively.
- Willingness to travel to clinical sites as required by study protocols.
Actalent provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
