MSD Senior Clinical Research Associate 

Vietnam, Hà Nội 

350458503

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country.
quality standardsand adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include, but are not limited to:

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study sitemanagement/monitoringactivities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth 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 on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased.
• Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits,monitoring visits,close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up,study maintenanceand study close-out.
• Communicates with Investigators and site staff on issues related to protocolconduct, recruitment,retention, protocol deviations, regulatory documentation, siteaudits/inspections andoverall 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 internally with Global Clinical Trial Operations, 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 strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training asappropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes tothe identificationof new potential sites and works closely with them to develop strongclinical researchcapabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate
• Could perform Quality control visits if delegated by other roles and trained appropriately.

• Fluent in Local Languages and English (verbal and written) and excellentcommunication skills,including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands-on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately, also in avirtual environment.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform comonitoring visits where appropriate.

• Effective time management, organizational and interpersonal skills, conflictmanagement, problemsolving skills.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense ofaccountability/urgency.Ability to set priorities and handle multipletasks simultaneouslyin a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish andmaintain culturallysensitive working relationships.
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistentwith organizationalpolicies and practices.

• Min. 4 years of direct site management (monitoring) experience in abio/pharma/CRO.

• B.A./B.S. with strong emphasis in science and/or biology, Pharmacy/Medicine

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.