Job Opportunity:
Start Up & HREC Submissions Associate
Are you a clinical research professional looking to take the lead in the initiation and approval of clinical trials? Do you thrive in a fast-paced, dynamic environment where attention to detail, regulatory knowledge, and collaboration are key? We want you to join our team as a Start Up & HREC Submissions Associate!
Overview:
In this role, you’ll be at the heart of clinical trial success, overseeing the preparation, submission, and management of ethics and regulatory documents for new studies. You’ll collaborate with cross-functional teams, ethics committees (HREC), regulatory bodies, and other stakeholders to ensure studies meet all necessary compliance standards and deadlines.
Key Responsibilities:
- Lead and manage the study start-up team to ensure the timely initiation of clinical trials, including feasibility assessments and site qualification visits.
- Stay ahead of regulatory requirements and ICH-GCP guidelines, ensuring submissions are in line with local and international standards.
- Collaborate with principal investigators, sponsors, and regulatory agencies to expedite study start-up and ethics submissions.
- Provide leadership and mentorship to the study start-up team, fostering a culture of excellence and continuous improvement.
- Develop and implement SOPs and best practices to optimize the study start-up process.
- Track ethics submission progress, ensuring transparency in communication and timely updates for all stakeholders.
- Offer expert guidance on HREC regulations, ensuring compliance with local practices and maintaining inspection readiness.
- Experience: 1-2 years in clinical research, especially in regulatory submission or study start-up coordination, preferably in an early-phase clinical trials environment.
- Skills: Strong organizational, planning, and time management abilities. You’ll be a proactive team player who excels in communication, both written and verbal, and can mentor junior team members.
- Technical Knowledge: In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements, with experience in clinical research coordination.
- Qualifications: A tertiary qualification in life sciences, health sciences, or a related field.
- Leadership Opportunity: Take charge of study start-up processes and make a direct impact on clinical trials.
- Collaborative Environment: Work with a dynamic team and engage with key stakeholders across the organization.
- Growth & Development: Continuously enhance your skills with ongoing training and development opportunities.
