Senior Clinical Research Associate

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

📋 Description

• Facilitate the identification, feasibility evaluation, and selection of investigators and sites for trial execution.

• Execute all monitoring tasks in accordance with the Monitoring Plan, ensuring monitoring visit reports are completed accurately and within the designated timeframe.

• Organize, prepare, and conduct site evaluation visits, providing comprehensive reports to aid in site selection.

• Prepare, submit, and collaborate with regulatory specialists regarding the development of regulatory packages, import/export requirements, and updates to Ethics Committee submissions.

• Negotiate site budgets, oversee site contract execution, track invoicing, and ensure prompt payment to sites.

• Plan, organize, and conduct site initiation visits.

• Create and maintain appropriate monitoring tools and project-specific documentation.

• Inspire and train investigators to ensure trial site personnel are well-versed in the protocol, investigational product, and trial requirements, enabling them to meet their obligations for accurate trial conduct and deadlines.

• Gather, review, and authorize essential documents from trial sites to ensure quality and compliance, while coding documents for Trial Master File (TMF) organization.

• Reconcile the contents of the in-house TMF with the site’s Investigator Site Files.

• Coordinate the distribution, tracking, handling, and disposal of investigational products and other trial supplies in accordance with site/trial specifications.

• Maintain trial information using the clinical trial management system and any other relevant tracking and reporting tools.

• Support initiatives aimed at enhancing recruitment efforts.

⛳️ Requirements

• Bachelor's degree; must hold a Bachelor of Science in Pharmacy Professional Regulation Commission License.

• At least 4 years of experience in clinical trial monitoring.

• Experience in Renal and/or Oncology clinical trials is advantageous.

• Exhibit practical knowledge of ICH-GCP guidelines and both global and local ethical and regulatory research requirements.

• Show proficiency in technical areas such as ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts, and clinical research design, along with issue escalation management.

• Demonstrate expertise in business skills including negotiation and conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Possess strong interpersonal communication and presentation skills, with the ability to work effectively within a multidisciplinary team, both independently and alongside a diverse range of stakeholders.

• Ability to adapt and remain flexible in response to changing organizational priorities and uncertain environments.

• Willingness and ability to travel as required.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your expertise and experience.

• Flexibility: Enjoy the option of hybrid or remote work arrangements based on your location and role.

• Career Growth: Access a wealth of learning opportunities and a global network of scientific leaders to support your professional development.

• Employee Wellbeing: Engage in programs and initiatives aimed at promoting work-life balance, health, and team connectivity, including global engagement surveys, recognition programs, and team-building activities.

• Global Opportunities: Join a company with an international presence, offering exposure to a variety of projects and clients.