Senior Clinical Research Associate

About the role

The Senior Clinical Research Associate will play a key role in the development and execution of clinical trials. This position requires strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously.

Responsibilities

• Manage and coordinate clinical trial activities, including study start-up, patient enrollment, and data management.
• Collaborate with cross-functional teams, including medical, regulatory, and operations teams, to ensure compliance with regulatory requirements and sponsor guidelines.
• Prepare and submit regulatory documents, such as Investigational New Drug (IND) applications, and maintain records of all clinical trial activities.
• Oversee the conduct of clinical trials, ensuring adherence to Good Clinical Practice (GCP) standards and regulatory requirements.
• Develop and implement strategies to enhance the efficiency and effectiveness of clinical trial processes.
• Provide training and mentorship to junior staff members.

Requirements

• A Master's degree in a relevant field (e.g., Biomedical Sciences, Pharmacy, etc.) or equivalent experience.
• At least 5 years of experience in clinical research, preferably in a pharmaceutical or biotech setting.
• Experience with regulatory submissions and compliance with GCP.
• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

Qualifications

• Knowledge of clinical trial design, conduct, and analysis.
• Experience with electronic data capture systems (EDC).
• Understanding of statistical principles and their application in clinical trials.
• Experience with regulatory submissions and compliance with GCP.

Skills

• Strong knowledge of clinical research protocols and procedures.
• Proficiency in Microsoft Office Suite.
• Experience with clinical trial management software (e.g., eCOA, eTMF).
• Excellent written and verbal communication skills.

Benefits

• Competitive salary commensurate with experience.
• Flexible work schedule, including remote work options.
• Health insurance coverage.
• Employee assistance program.
• Professional development opportunities.

Pay

Salary is competitive and commensurate with experience.

Schedule

This role offers a hybrid schedule, combining both remote and in-office work.