Senior Clinical Research Associate
Merck
VNM - Ho Chi Minh - Ho Chi Minh City (Le Duan)
4 ngày trước

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH / GCP and country regulations, Merck / MSD policies and procedures, quality standards and 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 site management / monitoring activities 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 : (1) Data generated at site are complete, accurate and unbiased, and (2) 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 maintenance and study close-out.

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 internally 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 strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate / required.

Supports and / or leads audit / inspection activities as needed.

Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Mentors / buddies junior CRAs on process / study requirements and performs co-monitoring visits where appropriate.

Requirement :

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

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.

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 analyze data / metrics and act appropriately, also in a virtual 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 co-monitoring visits where appropriate.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status : Regular

Relocation : No relocation

VISA Sponsorship :

Travel Requirements :

Flexible Work Arrangements :

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :

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