[Hiring] Clinical Research Associate II @Novotech Global

Role Description

• Build relationships with Principal Investigators, study coordinators, pharmacists, and relevant site trial personnel to ensure efficient management of clinical trials.
• Foster internal and external customer relationships for timely and productive project delivery as per study requirements and timelines.
• Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submission processes.
• Understand local and international regulatory requirements relevant to specific clinical trials in collaboration with the Regulatory Start-up (RSU) Team.
• Ensure recruitment of participants as per site target and drive site recruitment and engagement initiatives.
• Monitor investigational sites as per ICH GCP §5.18 and the Clinical Monitoring Plan (CMP), including all monitoring visit types across all phases of a clinical trial.
• Protect the rights and wellbeing of trial participants, including consent form checks, patient eligibility confirmation, and protocol compliance.
• Verify trial data accuracy and completeness, ensuring CRF data and queries are resolved per study timelines.
• Ensure proper storage, dispensing, accounting, and reconciliation of study drug as per the Clinical Monitoring Plan and Protocol.
• Maintain the project Trial Master File (TMF) in collaboration with IHCRA or DMA team throughout the study duration.
• Support sites to be audit and inspection ready.
• Keep all clinical trial management systems current and up to date with relevant trial data.
• Provide written and verbal site updates on study progress to the PM/LCRA as per study requirements and timelines.
• Collaborate with IHCRA and Site Contract Associates on-site payments, ensuring payment execution as per Clinical Trial Agreement terms.
• Assist the PM with the development of study-related project plans and templates as needed for successful study execution.

Qualifications

• Graduate in a clinical or life sciences-related field; relevant experience in allied professions may also be considered.
• Good time management skills and attention to detail.
• Able to work well in a team and be computer literate.
• Experience in the research or pharmaceutical industry preferred, with qualifications as follows:
• CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience in other roles in the Clinical industry.
• CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
• CRA IV: At least 4+ years of Clinical Research Associate experience in the Clinical industry.

Requirements

• Salary Band: $70,000 – 140,000; salary offered will be based on candidate's experience level.

Benefits

• Commitment to gender equality and providing an inclusive work environment.
• Flexible working options and paid parental leave for both parents.
• Flexible leave entitlements and wellness programs.
• Ongoing development programs.

Company Description

Novotech is proud to be a Circle Back Initiative Employer and commits to respond to every application. We look forward to discussing opportunities at Novotech.