CRA is responsible and accountable for deliverables of studies assigned to RCO unit, performing end to end study related onsite/ remote monitoring, quality data review, essential documents management for studies managed in-house with-in agreed timelines, budget and desired quality standards.
CRA is expected to adhere to required standard operating procedures, regulatory requirements, ICH GCP and quality in compliance with Sun Procedural Documents.
Area Of Responsibility
Ensures clinical trials are conducted at assigned sites as per protocol, local regulatory requirements, ICH GCP, ensure data integrity, patient safety and trials are conducted as per ethical standards (declaration of Helsinki).
Act as primary communication point between SPIL and clinical trial site w.r.t site management activities.
Facilitating regulatory submission
Perform site feasibilities, ensure site database is updated on periodic basis with feasibility results
Identify, plan and conduct Site Selection visits, ensure actions from SSV's are followed up with the assigned team.
Planning and performing IRB submissions in an efficient manner to secure timely approvals, ensure IRB/IEC dossiers are prepared and submitted as per site/IEC requirements.
Review of the Translated documents of the study
Negotiating study budgets with sites, ensure Clinical Trial Agreements are executed in timely manner
Ensure timely processing of the site invoices per the executed CTA and tracking all the site related payments during the conduct of the studies assigned.
Ensure the site related details are correctly & timely updated in the essential systems for assigned studies. (For e.g., Contact details of site/ PI/ HOI/ IEC)
Responsible to perform SIV and training to the study team. Ensure the sites are regularly trained on the study related documents, amendments, processes during conduct of the study.
Ensure planning and conducting of Onsite Monitoring Visits as per Site Monitoring Plan and follow up on the open action items in a timely manner.
Provide periodic updates to RTLs and management on study progress, deliverables, risks and quality.
Collaborate and lead communication with cross-functional units (Quality, DM, Medical team, and other stakeholders to ensure efficient conduct the study .
Ensure IMP supplies are adequate at sites and coordinate promptly with RTLs & Trial Operation Manager(s) for initial and resupply orders, manage IP supply scheme at site as per recruitment progress, ensure IMP supplies are received & stored per the protocol requirements.
Manage and ensure all the study protocol required supplies are adequate at the site(s) during conduct of the study (For e.g., Ancillary supplies, e-diaries, recruitment and patient facing & retention materials, Lab kits, etc.
Plan and track recruitment / retention strategies at site, ensure study recruitment risks are communicated pro-actively to RTLs and propose alternative solutions and actions are communicated and followed up to the investigator(s) in a timely manner.
Ensure compliance with Onsite visits, action items, PD & SAE reporting requirements along with meeting the interim and final DBL requirements of the assigned studies.
Ensure sites readiness for audits, inspections and actively involved in preparation and managing Sites for Audits, Inspection and quality/ oversight visits.
Review and ensure all the essential documents are filed in ITF and TMF
Perform sites closeout visits and follow up as per defined process
Coordinate with PI/site team to ensure sites have adequate time and fulfil their obligations to the study conduct.
Ensure the Visit reports/FU letters are timely submitted & approved and are sent/filed in TMF
Communicate/escalate compliance issues, trends noted to RTLs.
Ensure healthy relations & effective communication maintained with the site team.
Play an active role in planning, managing Investigator meetings
For Out-sourced Trials
Conduct accompanied visits with CRO monitor to ensure Quality, PI oversight, and site management.
Geographic Scope/ Market
India Cluster
Budget (if applicable)
Regional Clinical Operations Unit Budget
Work Conditions
Full time
Physical Requirements
Presence at work
Travel Estimate
Frequent
Education and Job Qualification
Minimum Pharmacy Graduate (04 Years.) or Post Graduate in pharmacy and other science/healthcare fields. Added qualifications will be preferred.
Experience
CRA Should have at-least 3 years of experience in clinical research field and at-least 02 years of onsite monitoring experience for Phase II/III global clinical trials.
