Job Summary
The Senior Clinical Research Associate (CRA) plays a pivotal role in overseeing clinical trials, specifically focusing on rare diseases or oncology. This position, primarily located in the East Coast or Central US, involves working closely with study teams to ensure that clinical trials are conducted in compliance with regulatory requirements and organizational standards. The Senior CRA is responsible for the quality of data collected and the integrity of the trials.
Responsibilities
- Lead the monitoring of clinical trial sites and ensure adherence to protocol and regulatory standards.
- Collaborate with cross-functional teams to support clinical trial operations.
- Conduct site initiation, monitoring, and closeout visits to assess trial compliance.
- Review and verify site documentation, including source data, to ensure accuracy and compliance.
- Provide training and mentorship to junior CRAs and site personnel on study protocols and procedures.
- Act as a key point of contact for site inquiries and facilitate effective communication between stakeholders.
Qualifications
- A bachelor’s degree in life sciences or a related field.
- At least 3-5 years of experience as a Clinical Research Associate, with a focus on rare diseases or oncology preferred.
- In-depth knowledge of clinical trial processes, regulations, and GCP guidelines.
- Excellent organizational and communication skills, with the ability to manage multiple tasks and deadlines.
- Strong problem-solving abilities and attention to detail.
- Willingness to travel to clinical sites as required by trial protocols.
