Senior Clinical Research Associate
• Formerly known as AEM IMED (Asia & Emerging Markets, Innovative Medicines and Early Development), AstraZeneca; in 2017, company was founded as a research-based biotechnology company
Roles & Responsibilities:
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 guiding 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.
Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software
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 esp when its related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients’ rights and wellbeing.
University degree in related discipline, preferably in life science, or equivalent qualification.
At least 2-years clinical research working experience in multinational pharmaceutical companies or multinational CROs is preferred.
Fluent knowledge of spoken, read and written English.
Excellent knowledge of international guidelines ICH/GCP.
Good knowledge of relevant local regulations.
Good medical knowledge and basic understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
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.