Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Research Associate (Level I/ II) – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to coordinate and oversee all clinical aspects of a study for assigned sites from start-up to close-out, as applicable per study specifications and as defined in CRG SOPs and Task Matrix. As a Clinical Research Associate (Level I/ II), you'll be competent and enhancing proficiency in remote and onsite monitoring. You will perform site monitoring activities and review subject data on an ongoing basis in line with CRG and/or Client procedures. You will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with client company personnel and investigational sites. You will contact study sites to discuss study status, monitoring findings and issues, and request outstanding information and documentation. You will trigger on-site monitoring, indicating areas of focus to ensure that pertinent tasks and identified findings are addressed. You will play an active role within the clinical team to reach clinical goals, achieve deliverables, and meet project deadlines. Additionally, you may mentor and onboard more junior colleagues.
What You’ll Do:
- Manage client relationships and serve as a primary point of contact for assigned clinical trials
- Conduct on-site monitoring visits in accordance with client SOPs and project-specific requirements
- Perform risk-based monitoring activities, including source data verification and source document review
- work on client systems including CTMS, EDC, IWRS, eTMF etc.
- Support in maintaining the country metrics
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements
- Collaborate with clinical sites to resolve issues and maintain study integrity
- Prepare and submit accurate, timely monitoring reports and follow-up letters
- Participate in client meetings and provide regular updates on study progress
- Routinely complete all assigned CRG, Client and project specific trainings
- Support in site audits/ inspections and assist in the development and implementation of corrective and preventive actions (CAPAs)
- Takes ownership for follow up on identified risks/issues through to successful resolution.
- Contribute to the continuous improvement of monitoring processes and guidelines
- Travel to clinical sites as per the monitoring plan (up to 60-75% travel may be necessary)
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience Requirements:
- Postgraduate degree in Life Sciences or a related field
- Minimum of 1-1.5 years of on-site monitoring experience in clinical trials (Mandate)
- Demonstrated knowledge of ICH GCP guidelines and applicable regulatory requirements
- Experience working in an FSP model is preferred (not mandatory)
- Valid Drivers' license where applicable
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Strong client management skills with the ability to build and maintain positive relationships
- Excellent knowledge of clinical research processes and medical terminology
- Proficiency in following and interpreting client-specific SOPs
- Strong attention to detail and ability to maintain accurate records
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team
- Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems
- Ability to work on multiple projects simultaneously and prioritize optimally
- Problem-solving skills and the ability to make sound judgments
- Flexibility to adapt to changing client needs and project requirements
- Ability to perform monitoring visits as per Risk Based Quality Management (RBQM) concepts and processes
- Ability to work in a team or independently as the need arises
- Digital literacy and proven knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills