Clinical Research Associate CRA

Accountabilities

• Independently manage clinical monitoring activities, ensuring compliance with protocols, regulatory standards, and quality expectations.
• Perform qualification, initiation, interim, and close-out monitoring visits remotely and onsite while ensuring accurate documentation and compliance.
• Conduct source document review, verify clinical data, and perform quality checks to maintain data integrity throughout clinical trials.
• Prepare and submit timely and accurate monitoring visit reports detailing site performance, protocol deviations, corrective actions, enrollment progress, and study status.
• Maintain investigational product accountability and review regulatory documentation maintained at study sites.
• Monitor site compliance with clinical protocols, ICH GCP guidelines, FDA regulations, and applicable sponsor procedures.
• Maintain regular communication with investigators and site teams to support recruitment, resolve issues, and address study-related questions.
• Identify risks and operational challenges proactively, developing solutions to improve site performance and study delivery.
• Collaborate with project managers, lead CRAs, data management teams, and other clinical functions to resolve data discrepancies and operational issues.
• Support the development of study-specific monitoring plans, training materials, and site management strategies.
• Participate in sponsor meetings, internal meetings, audits, and clinical research initiatives as needed.
• Assist with CRA onboarding, mentoring, and knowledge-sharing activities.
• Contribute to the maintenance and improvement of clinical trial management systems and operational processes.
• Manage competing priorities effectively while delivering commitments within project timelines and budgets.

Requirements

• Bachelor’s degree in Biology, Life Sciences, healthcare, or a related scientific field.
• Experience working as a Clinical Research Associate or in a comparable clinical monitoring role.
• Strong knowledge of clinical research processes, ICH GCP guidelines, regulatory requirements, and ethical standards.
• Experience conducting site qualification, initiation, monitoring, and close-out visits.
• Ability to establish and maintain positive relationships with sponsors, investigators, site teams, and internal stakeholders.
• Strong organizational skills with the ability to prioritize multiple activities and meet deadlines.
• Excellent analytical, problem-solving, and decision-making abilities.
• Strong communication, negotiation, and meeting management skills.
• Detail-oriented approach with a strong commitment to quality and accuracy.
• Able to work independently while contributing effectively within collaborative teams.
• Experience using clinical trial management systems, electronic data capture platforms, and clinical databases.
• Professional communication skills in English, both written and verbal.
• Ability and willingness to travel as required for site monitoring activities.
• Able to manage changing priorities, ambiguity, and challenging situations with professionalism.

Benefits

• Competitive compensation based on location, experience, skills, qualifications, and role scope.
• Remote work flexibility with opportunities to collaborate in a global clinical research environment.
• Professional development opportunities and continued learning support.
• Exposure to innovative healthcare and life sciences projects.
• Opportunity to work with multidisciplinary teams across clinical research, technology, and healthcare domains.
• Flexible work programs designed to support work-life balance.
• Global collaboration opportunities with professionals from diverse backgrounds.
• Career growth opportunities within a mission-driven organization focused on improving healthcare outcomes.