Participate in the coordination of and contribute to operational activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives during overall study management life cycle in country level.
Participate in CRA training program, if qualified after evaluation after LM, who will participate in site management as CRA role.
Responsibility:
1. Site management
? Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study team to ensure that quality commitments are achieved in a timely and efficient manner.
? Conduct site feasibility assessment.
? Contribute to the selection of potential investigators and leading investigator.
? Contribute to national Investigator meeting.
? Obtain and maintain essential documentation in compliance with international guidelines ICH-GCP, Company procedural documents and local regulations both in the office and at site.
? Actively participate in local Study Team meetings. Share information on patient recruitment and study site progress within local Study Team. Good knowledge in relevant Therapeutic area to train, support and advice Investigators and site staff in study related matters.
? Initiate monitor and close study sites in compliance with Company procedural Documents. Ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.
? Drive performance at the sites.
? Update study related systems with data from sites per required timelines.
? Manage study supplies, drug supplies and drug accountability at study sites.
? Perform source data verification. Proactively identify study-related issues and escalates as appropriate.
? Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.
? Ensure accurate and timely reporting of Serious Adverse Events.
? Work with data management to ensure quality of the study data. Ensure data query resolution.
? Prepare for activities associated with audit and regulatory inspection at responsible sites and/country in liaison with local study team lead and QA.
? Responsible for completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
? Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent especially when it’s related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients' rights and wellbeing.
2. Management and Relationship Responsibilities
? Provide clear guidelines and share information with investigators on study objectives and procedures to build their understanding of expectations and targets.
? Motivate and support investigators and site staff to achieve target patient recruitment, identifying issues and liaising with site staff to develop solutions.
? Set up the close connection with KOLs and field thought leaders, maintain the good relationship with the cooperated sites.
Requirement:
? Good medical knowledge and basic understanding of the drug development process.
? Fluent knowledge of spoken, read and written English.
? Team oriented and flexible. Ability to manage & prioritize multiple tasks with conflicting deadlines ability to work in an environment of remote collaborators
? Meticulous and detail-oriented
? Ability to travel nationally as required.