Senior - Clinical Research Associate (vaccine)-Mumbai, Gurgaon

Job Description

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members.

Responsibilities:

• Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalate observed deficiencies and issues to clinical management expeditiously, present solutions and follow all issues through to resolution. Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participate in investigator meetings as necessary. Identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensure trial close out and retrieval of trial materials
• Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
• Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assist in project specific training for the clinical team where necessary. Identify areas for potential process improvements & share potential solutions for improvements.
• Perform additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensure study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
• Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Respond to company, client and federal regulatory requirements/audits.
• Maintain & complete administrative tasks such as expense reports and timesheets in a timely manner

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