Clinical Research Associate (II-SCRA) (Southeast)

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 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 ethics and regulatory submission and approval processes
• In collaboration with Regulatory Start-up (RSU) Team, understand applicable local and international regulatory requirements as relevant to specific clinical trials
• Ensure recruitment of participants as per site target; drive site recruitment and engagement initiatives and prepare site-specific recruitment plans
• Monitor investigational sites as per ICH GCP §5.18 and the Clinical Monitoring Plan (CMP), including Site Selection, Site Initiation, Site Monitoring, Site Close Out, unblinded pharmacy visits, and co-monitoring visits
• Ensure rights and wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs
• Verify trial data are accurate and complete; ensure CRF data and queries are completed and resolved per study timelines
• Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled per the CMP and Protocol
• In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete throughout the study
• Support sites to be audit and inspection ready
• Ensure all clinical trial management systems are current and up to date with all relevant trial data
• Provide written and verbal site updates, including monitoring visit reports, on study progress to the PM/LCRA per study requirements and timelines
• Collaborate with IHCRA and Site Contract Associates on site payments to ensure payment execution as per the Clinical Trial Agreement
• Assist the PM with development of study related project plans and templates 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
• CRA III: At least 4+ years of Clinical Research Associate experience in the Clinical industry