Clinical Research Associate (II-SCRA) (Central)

Responsibilities

• Build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.
• Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
• In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
• In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
• Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
• Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study, including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co monitoring visits.
• Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs.
• Ensure safety issues are reported to the sponsor promptly.
• Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
• Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
• In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study.
• Support sites to be always audit and inspection ready.
• Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
• Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.
• Escalate all key issues as per Issue Escalation SOP.
• Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement.
• Assist the PM with the development of study related project plans and templates as per study requirements and support tasks as needed for successful study execution.

Qualifications

• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
• Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
• CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
• CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
• Sr. CRA: At least 3-5 years of Clinical Research Associate experience in the Clinical industry.