Job Description
Are you ready to shape the future of healthcare?
Apex BioPharma Solutions is a leading biotechnology firm dedicated to accelerating the development of life-saving therapies. We are currently seeking a highly motivated Clinical Research Associate (CRA) to join our dynamic Regulatory Affairs team in Boston, MA. In this pivotal role, you will oversee clinical trials from inception to completion, ensuring data integrity, patient safety, and regulatory compliance.
We offer a competitive benefits package, a collaborative work environment, and the opportunity to work on groundbreaking treatments that improve millions of lives worldwide.
Responsibilities
- Conduct on-site monitoring visits to clinical trial sites to ensure protocol adherence and data accuracy.
- Monitor the progress of clinical trials, ensuring they are conducted in accordance with Good Clinical Practice (GCP) and regulatory standards.
- Review and verify Investigator Site Files (ISFs) for completeness and regulatory compliance.
- Identify, assess, and report Serious Adverse Events (SAEs) to the IRB and sponsor in a timely manner.
- Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Regulatory Affairs.
- Manage communications with investigators, study coordinators, and sponsor representatives to resolve issues efficiently.
- Prepare and submit accurate regulatory documentation and trial status reports.
Qualifications
- Bachelor’s degree in Nursing, Life Sciences, Biology, or a related field required.
- Minimum of 2-4 years of experience in clinical research, clinical trials, or a related healthcare role.
- Strong working knowledge of ICH-GCP guidelines, FDA regulations, and EMA standards.
- Ability to travel up to 50% of the time to various clinical trial sites.
- Excellent written and verbal communication skills with a focus on detail.
- Proficiency in electronic data capture (EDC) systems (e.g., Oracle Clinical, Medidata Rave) is a plus.
- Certification as a Regulatory Affairs Professional (RAC) or similar is preferred.