[Hiring] Clinical Research Associate @Novotech Global

Role Description

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Key Responsibilities

• Build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure efficient management of clinical trials.
• Foster internal and external customer relationships for timely and productive project delivery.
• Prepare site essential documents in collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA).
• Understand local and international regulatory requirements relevant to specific clinical trials.
• Ensure recruitment of participants as per site targets and drive site recruitment initiatives.
• Monitor investigational sites according to ICH GCP and the Clinical Monitoring Plan (CMP) for each study.
• Protect the rights & wellbeing of trial participants, including consent form checks and safety issue reporting.
• 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 drugs as per the CMP and Protocol.
• Keep the project Trial Master File (TMF) up to date throughout the study duration.
• Support sites to be audit and inspection ready.
• Maintain current clinical trial management systems with all relevant trial data.
• Provide written and verbal site updates on study progress to the PM/LCRA.
• Collaborate on-site payments with IHCRA and Site Contract Associates, ensuring payment execution as per Clinical Trial Agreement.
• Assist the PM with the development of study-related project plans and templates.

Qualifications

• Graduate in a clinical or life sciences-related field.
• Relevant experience/qualifications 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.
• 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.
• Senior CRA (SCRA): At least 3-5 years of Clinical Research Associate experience in the Clinical industry.
• Fluency in French is highly prioritized.

Benefits

• Flexible working options.
• Paid parental leave for both parents.
• Flexible leave entitlements.
• Wellness programs.
• Ongoing development programs.

Company Description

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. We are looking for people who are passionate about working in clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application.