Job Summary
The Senior Clinical Research Associate (CRA) role focuses on overseeing clinical trials in the Central U.S. with a specialization in Central Nervous System (CNS) and rare diseases. This position allows for remote work and is integral in ensuring that clinical research activities comply with regulatory requirements and standard operating procedures.
Responsibilities
- Manage and monitor the progress of clinical trials, ensuring adherence to protocols and timelines.
- Conduct site evaluations and assessments for potential clinical trial participation.
- Facilitate communication between study sites and sponsors to ensure clarity and support throughout the study process.
- Collect and review study data to ensure accuracy and compliance, addressing any issues that arise promptly.
- Prepare necessary documentation for regulatory submissions and support audits as needed.
- Act as a mentor for junior CRAs and provide training as necessary.
Qualifications
- A minimum of a Bachelor’s degree in a life sciences discipline or a related field.
- Experience as a CRA with a focus on CNS and rare disease studies is preferred.
- Strong understanding of Good Clinical Practice (GCP) and regulatory guidelines.
- Excellent communication and interpersonal skills for effective collaboration with diverse stakeholders.
- Ability to work independently and manage multiple responsibilities within timelines.
- Proficiency with electronic data capture systems and other clinical trial management tools.
