[Hiring] Clinical Research Associate @Novotech Global

Role Description

The Clinical Research Associate (CRA) is responsible for building and maintaining strong relationships with Principal Investigators, Study Coordinators, Pharmacists, and other site staff to ensure the successful execution of clinical trials. The CRA oversees site management activities, monitoring visits, regulatory compliance, participant recruitment, investigational product accountability, and data quality to ensure studies are conducted in accordance with ICH-GCP, protocol requirements, applicable regulations, and company SOPs. The CRA serves as a key liaison between study sites, sponsors, and internal project teams, ensuring efficient, timely, and high-quality project delivery across all phases of clinical trials.

Key Responsibilities

• Build and maintain effective relationships with Principal Investigators, Study Coordinators, Pharmacists, and other site personnel.
• Act as the primary contact for assigned sites and provide ongoing support throughout the study lifecycle.
• Foster strong internal and external relationships to support efficient and timely study delivery.
• Collaborate with IHCRA, RSA, and RSU teams on site documentation, ethics submissions, regulatory approvals, and applicable regulatory requirements.
• Support sites in achieving recruitment targets and develop site-specific recruitment and engagement plans.
• Monitor recruitment performance and proactively address enrollment and retention challenges.
• Conduct SSV, SIV, routine monitoring, COV, remote, pharmacy, and co-monitoring visits in accordance with ICH GCP §5.18, protocols, CMPs, and SOPs.
• Ensure participant rights, safety, and well-being are protected, including informed consent, eligibility, protocol compliance, and investigational product compliance.
• Review AEs, SAEs, and safety documentation and ensure timely escalation and reporting of safety issues.
• Verify clinical trial data for accuracy, completeness, and integrity.
• Ensure timely CRF completion, query resolution, and identification and escalation of data quality issues.
• Verify appropriate investigational product storage, dispensing, accountability, reconciliation, and destruction.
• Collaborate with IHCRA/DMA teams to maintain complete, accurate, and inspection-ready TMF documentation.
• Support sites in maintaining audit and inspection readiness and assist with audits and regulatory inspections.
• Maintain accurate and timely study information in CTMS and other clinical systems.
• Prepare monitoring visit reports and provide regular written and verbal study updates to PMs/LCRAs.
• Escalate significant issues in accordance with applicable SOPs and escalation procedures.
• Collaborate with IHCRA and Site Contract Associates to ensure site payments are processed accurately and in accordance with Clinical Trial Agreement terms.
• Assist Project Managers with study planning, documentation, deliverables, and timelines.
• Maintain strong knowledge of ICH-GCP, Declaration of Helsinki, and applicable local and international regulations.
• Adhere to company policies, procedures, SOPs, and quality standards.
• Contribute to process improvement initiatives and development of clinical SOPs.
• Participate in Clinical Operations meetings, departmental initiatives, presentations, and knowledge-sharing activities.
• Support feasibility activities and maintain strong site relationships to support future study opportunities.
• Identify and communicate potential business development opportunities.

Qualifications

• Bachelor's Degree in Life Sciences, Nursing, Pharmacy, Medicine, Biotechnology, or a related scientific discipline.
• Advanced degree preferred.
• Minimum 2 years of clinical research experience in a CRA role.
• Experience monitoring Phase I-IV clinical trials.
• Experience working with CROs, pharmaceutical, or biotechnology companies preferred.
• Experience with remote and onsite monitoring activities.
• Strong knowledge of ICH-GCP and applicable regulatory requirements.
• Understanding of clinical trial processes and monitoring methodologies.
• Excellent communication and relationship management skills.
• Strong problem-solving and analytical abilities.
• Ability to manage multiple projects and priorities simultaneously.
• High attention to detail and quality.
• Proficiency in CTMS, EDC systems, Microsoft Office Suite, and TMF platforms.
• Ability to travel domestically and internationally as required.

Benefits

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