Job Summary
The Clinical Research Associate II position plays a key role in the management and oversight of clinical trials. The incumbent will contribute to the successful execution of clinical research projects in a variety of therapeutic areas. This position is open to candidates located throughout the United States and will operate under a functional service provider model, ensuring compliance with regulatory standards and company policies.
Responsibilities
- Coordinate and manage the activities involved in clinical study monitoring to ensure compliance with protocols, company policies, and regulatory requirements.
- Prepare, review, and maintain necessary documentation related to clinical studies, ad hoc reports, and meeting minutes.
- Conduct regular monitoring visits and ensure timely follow-up on issues arising during the trial conduct.
- Actively collaborate with cross-functional teams to facilitate project timelines and clinical trial milestones.
- Support site selection, study initiation, and training activities for involved staff at clinical sites.
Qualifications
- Bachelor’s degree in life sciences or a related field is required; advanced degrees are a plus.
- A minimum of 2 years of experience in clinical research monitoring or similar roles within the pharmaceutical or biotechnology sectors.
- Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent organizational, analytical, and communication skills, along with attention to detail.
- Ability to work independently and effectively manage multiple priorities in a fast-paced environment.
Parexel 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.
