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Clinical Research Associate I
2 months ago
Parexel is seeking a highly skilled Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for managing clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals.
Key Responsibilities- Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff, conduct feasibility and/or site pre-qualification and qualification activities, and generate visit/contact reports.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents.
- Prepare and submit IRB/IEC and Mo H/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Forecast, develop, manage, and revise plans and strategies for IRB/IEC and Mo H / RA submission/approval, site activation, patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.
- Ensure timely and accurate completion of project goals and update of applicable trial management systems.
- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites.
- Manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- Ensure that assigned sites are audit and inspection ready.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate.
- Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
- Show commitment and perform consistent high quality work.
- Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
- Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
- Provide input and feedback for Performance Development Conversation(s).
- Proactively keep manager informed about work progress and any issues.
- Develop expertise to become a subject matter expert.
- Work in a self-driven capacity, with limited need for oversight.
- Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.).
- Problem solving skills.
- Able to work independently, seeking/taking guidance when necessary.
- Sound presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization with the support of manager or CRAII/III.
- Flexible attitude with respect to work assignments and new learning.
- Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Developing ability for effective time management in order to meet study needs, team objectives, and department goals.
- Developing ability to work across cultures.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a ('virtual') team environment.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.
- Holds a driver's license where required.
- Previous relevant work experience preferred.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
