Clinical Site Activation Specialist

2 weeks ago

Delhi, Delhi, India Lifelancer Full time
Clinical Site Activation Specialist Job Description

Lifelancer is seeking a Clinical Site Activation Specialist to join our team in the pharmaceutical industry. In this role, you will be responsible for leading or supporting operational activities from startup to closeout for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

  • Initiate and coordinate activities and essential documents management during startup towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable.
  • Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form for internal regulatory approval within required timelines.

Key Responsibilities:

Clinical Trial Site Activation

• Initiate and coordinate activities and essential documents management during startup towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.

• Provide support to resolve issues or concerns and timely escalation of Site issues where applicable.

• Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form for internal regulatory approval within required timelines.

• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.

• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.

• Coordinate the timely communication, documentation, and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent).

• Support investigators sites with local IRB workflow from preparation, submission through approval.

• Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.

• Support implement activities in Shared Investigator Platform to align with Pfizer strategy as it relates to the role.

Clinical Trials Conduct

• Post site activation, initiate and coordinate activities and essential documents management with the investigators sites towards the compilation of a high-quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals, and other activities required during study conduct.

• Ensure maintenance of IRB/Ethics and other committees activities as applicable.

• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness.

• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.

• Supports investigator sites and study teams in preparation for and providing responses to site audits/inspections.

Internal, External Communication

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.

• Provide functional updates on a country and site level as required.

• Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.

• Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable.

• Communicate Local sites approvals to study team members and stakeholders.

Clinical Trial Site Support

• As needed, perform awareness session with site personnel on Pfizer requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

• Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence/persistence of issues.

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