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.
