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Centralized Monitoring Asst
Ahmedabad, India | Kochi, India | Noida, India | India
Full-time
R1422531
Job Description
Job Overview
Provide project-related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices, and applicable regulatory requirements. Meeting quality and timeline metrics.
Essential Functions
- Complete appropriate role-specific training to perform job duties.
- Under supervision, provide study-level administrative support to the clinical study management team (examples of such tasks include, but are not limited to, running system reports, preparing and distributing status reports, creating and maintaining study trackers, following up on outstanding issues, etc.).
- Under supervision, assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis.
- Perform the activities as per the task list delegated by CMS leads.
- Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies by pulling associated reports.
- Perform assigned access management-related administrative tasks to support team members with project execution. Examples of tasks include, but are not limited to, processing access requests and following up with relevant vendors.
- Provide support to technical solution specialists (TSS) on formulations in Excel and on the front-end part.
- Periodic review of site-level KRIs and historic site performance according to the Central Monitoring Plan.
- Facilitate early identification of site-level risk/issue(s) occurring during study conduct and be responsible for identification of risk.
- Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit).
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.
- Review the Study Central Monitoring Plan.
- Attend Kick-Off meetings, weekly team meetings, and client meetings as needed or requested.
- Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
- Graduate/Post Graduate in Life Sciences or educational equivalent.
- Requires a minimum of 2 years of work experience with at least 6 months of relevant experience.
- Equivalent combination of education, training, and experience may be considered. Experience level may vary based on customer-specific requirements.
- Basic knowledge of applicable research and regulatory requirements, i.e., International Conference on Harmonisation – Good Clinical Practice and relevant local laws, regulations, and guidelines.
- Exposure to Microsoft Applications, including but not limited to Microsoft Word, Excel, and PowerPoint.
- Effective written and verbal communication skills, including good command of the English language.
- Effective time management skills.
- Results- and detail-oriented approach to work delivery and output.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Strong listening and phone skills.
- Good data entry skills.
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