Clinical Research Associate

1 week ago

Hanoi, Hanoi, Vietnam MSD Full time

Job Description:

THE OPPORTUNITY

  • Permanent Headcount with International Pharmaceutical company
  • Multiple therapeutic area study to explore your clinical experience
  • Best team and career development with company

WHAT YOU WILL DO

  • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gains an indepth understanding of the study protocol and related procedures.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and onsite monitoring & oversight activities using various tools to ensure Data generated at site are complete, accurate and unbiased.
  • Subjects' right, safety and wellbeing are protected.
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit contact reports appropriately in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
  • Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
  • Supports and/or leads audit/inspection activities as needed.
  • Performs comonitoring visits where appropriate.
  • Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

WHAT YOU MUST HAVE

Experience Requirements:

  • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

  • Preferred: B.A./B.S. with strong emphasis in science and/or biology
  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Hands on knowledge of Good Documentation Practices.
  • Proven Skills in Site Management including management of site performance and patient recruitment.
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Ability to understand and analyse data/metrics and act appropriately.
  • Capable of managing complex issues, works in a solutionoriented manner.
  • Performs root cause analysis and implements preventative and corrective action.

WHAT YOU CAN EXPECT

  • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
  • Demonstrated high level of monitoring skill with independent professional judgement.
  • Able to work highly independently across multiple protocols, sites and therapy areas.
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus.
  • Works with high quality and compliance mindset.
  • Positive mindset, growth mindset, capable of working independently and being selfdriven.
  • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Research & Development Division
We are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world.

And we believe that a research-driven

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