Study Start Up Associate II

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Oversee the initiation of clinical trial site activities, ensuring timely preparation and approval of regulatory documents.

• Manage submissions and approvals from the Institutional Review Board (IRB).

• Tailor and negotiate informed consent forms (ICFs) for sites.

• Gather essential regulatory documents required for the trials.

• Assist with the enrollment process, follow-up, and closure of clinical trial operations.

• Coordinate regulatory submissions and document collection for designated clinical research sites.

• Administer regulatory documentation across various studies and division portfolios.

• Foster relationships with clinical research sites and offer regulatory expertise during the start-up phase.

• Monitor timelines for IRB/EC submissions and track approval statuses.

• Address and resolve challenges during the site start-up phase to uphold service-level agreements and project objectives.

• Prepare, complete, and monitor regulatory, ICF, and legal documents.

• Document the readiness of sites and investigators across multiple studies.

• Assist with internal quality audits and regulatory inspections.

• Maintain trackers for study start-up and close-out, site metrics, and documentation within CTMS/eTMF systems.

• Provide updates to leadership regarding start-up activities, investigator preparedness, and regulatory compliance.

• Raise issues to investigators, site coordinators, clinical study leaders, and other relevant stakeholders.

• Ensure adherence to ICH/GCP, MDR, GDPR, SOPs, work instructions, policies, and procedures.

⛳️ Requirements

• Bachelor’s Degree or a comparable combination of education and experience.

• A minimum of 2 years of experience in clinical or scientific research.

• Experience with medical devices, particularly in clinical study site start-up within the United States.

• Capability to manage multiple studies and/or personnel concurrently in a dynamic environment.

• Ability to function efficiently in a team-oriented setting.

• Strong written and verbal communication skills, with the ability to present information clearly and concisely.

• Comfortable communicating with clinical research site personnel via phone and email.

• Remote working position.

• Preferred: Experience as a Research Coordinator, In-House Clinical Research Associate, Clinical Research Associate, or Study Start-Up Specialist.

• Preferred: Familiarity with clinical trial management systems, such as Siebel CTMS or Veeva.

• Preferred: Knowledge of clinical document control systems/eTMF.

• Strong emphasis on customer service.

• Proficiency in English.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Comprehensive health and wellbeing programs, including medical, dental, and vision coverage when applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and resources for wellbeing.

• Opportunities for learning and professional development through structured training and career advancement pathways.