Senior Clinical Research Associate

3 weeks ago

Makati City, National Capital Region, Philippines MSD Full time
Job Description

The role is responsible for overseeing performance and compliance for designated protocols and sites within a country. Working under the supervision of the CRA manager or CRD, the individual ensures that the study is conducted in adherence to ICH/GCP and local regulations, company policies, quality standards, and reporting requirements for adverse events both internally and externally. Serving as the main point of contact for sites, the person carries out site management duties throughout all stages of a clinical research study, assuming overall site responsibility. Actively involved in expanding the territory for clinical research by identifying and cultivating new sites. Additionally, they partake in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.


Responsibilities:

  • Build strong relationships with sites and ensure continuity across all trial phases.
  • Conduct clinical study site management activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and related documentation.
  • Gain a thorough understanding of the study protocol and associated procedures.
  • Coordinate and manage tasks in collaboration with other team members to prepare sites for study initiation.
  • Participate in site selection and validation activities.
  • Perform remote and on-site monitoring to ensure data accuracy and subject safety.
  • Conduct various site visits and maintain necessary regulatory documentation.
  • Communicate with Investigators and site staff regarding protocol compliance, recruitment, and overall site performance.
  • Identify and resolve site performance issues, escalating when necessary.
  • Collaborate internally with different departments and externally with vendors and regulatory authorities.
  • Maintain information and documentation in relevant systems.
  • Contribute to team knowledge by sharing best practices and providing training.
  • Support audit/inspection activities as required.
  • Assist in identifying new potential sites based on the country strategy.
  • Mentor junior team members and perform co-monitoring visits.
  • Assist in Quality control visits if needed and trained.

CORE Competency Expectations:

  • Fluency in Local Languages and English with excellent communication skills.
  • Strong understanding of clinical research, GCP/ICH guidelines, and local regulations.
  • Ability to mentor and lead effectively.
  • Hands-on experience in site management and patient recruitment.
  • Proficient in Good Documentation Practices.
  • Skilled in data analysis and IT applications.
  • Experience in conducting motivational visits for site enrollment.
  • Effective problem-solving skills and ability to manage complex issues.
  • Positive and growth-oriented mindset with a focus on quality and compliance.

Behavioural Competency Expectations:

  • Strong time management and organizational skills.
  • Ability to work independently across multiple protocols and therapy areas.
  • High sense of accountability and ability to handle multiple tasks efficiently.
  • Works well in a diverse, multicultural environment.
  • Emphasis on Customer focus and quality mindset.
  • Positive and professional demeanor in communication and behavior.

Experience Required:
Minimum of 4 years direct site management experience in bio/pharma/CRO industry.
Educational Requirements:
Preferred: B.A./B.S. with emphasis in science or biology

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 05/27/2024

Requisition ID: R294442

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