Job Summary
The Senior Clinical Research Associate (SCRA) plays a pivotal role in overseeing and managing the clinical trial process, ensuring the adherence to regulatory standards and company protocols. The SCRA is responsible for coordinating and monitoring various aspects of clinical studies, contributing significantly to the successful execution of research projects.
Responsibilities
- Oversee clinical trial management from initiation through to closure, ensuring compliance with regulatory requirements.
- Monitor trial progress, data integrity, and participant safety while collaborating effectively with investigative sites.
- Facilitate the development and maintenance of study plans and documentation, ensuring accuracy and completeness.
- Conduct site visits to evaluate site performance and support site staff in trial execution.
- Provide training and guidance to junior clinical staff and site personnel regarding trial protocols and procedures.
- Prepare reports and presentations summarizing trial progress and outcomes for stakeholders.
- Collaborate with cross-functional teams to enhance study design and implementation strategies.
Qualifications
- Bachelor’s degree in a related field; advanced degree is a plus.
- Proven experience in clinical trial monitoring, preferably in a senior role.
- In-depth knowledge of GCP, regulatory requirements, and clinical research methodologies.
- Strong analytical and problem-solving skills, with the ability to manage multiple tasks and prioritize effectively.
- Excellent communication and interpersonal skills, able to work collaboratively with various stakeholders.
- Capacity to mentor and lead junior team members, fostering a supportive work environment.
- Ability to travel to clinical sites as required for monitoring visits.
