Cra Junior

Merck; Buenos Aires; Sur place; ARS 1 000 000 - 1 400 000; Plein temps

Résumé du poste

Merck is seeking an experienced Clinical Research Associate to act as the primary site contact and site manager across all trial phases. You will build strong site relationships, perform on-site monitoring, and ensure regulatory documentation aligns with ICH-GCP and Sponsor SOPs.

You will collaborate with CRA teams and other sponsor functions to achieve Site Ready, participate in site selection, and manage visits and reports in CTMS/eTMF, supporting audits as needed.

Qualifications

• BS/BA in science or related field; clinical research exposure.
• Minimum 2 years of clinical research experience.
• Experience with regulatory documentation and site management.

Responsabilités

• Act as primary site contact and site manager through all trial phases.
• Develop and maintain strong site relationships for continuity.
• Perform site management/monitoring per ICH-GCP and sponsor SOPs.
• Coordinate tasks with sponsor roles to achieve Site Ready.
• Conduct site visits (validation, initiation, monitoring, close-out) and prepare reports.
• Collect and monitor regulatory documents for start-up, maintenance, and close-out.
• Communicate with investigators on protocol conduct, recruitment, and deviations.
• Identify and resolve site performance or compliance issues with escalation as needed.
• Collaborate with country operations, regulatory, pharmacovigilance, and external partners.
• Maintain documentation in CTMS/eTMF and other systems; support audits/inspections.
• Possibly perform co-monitoring when appropriate.

Connaissances

Site management

On-site monitoring

ICH-GCP

Regulatory compliance

Data analysis

Communication skills

Problem solving

Formation

B.A./B.S. in science

Outils

CTMS

eTMF

MS Office

Description du poste

Job Description

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

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:

• 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 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 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.

Supports audit/inspection activities as needed.

Performs co-monitoring where appropriate.

Competency Expectations

Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.

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 CRA Guidelines and ability to work within these guidelines.

Hands on knowledge of Good Documentation Practices

Developing skills in Site Management including management of site performance and patient recruitment

Developing level of monitoring skill and independent professional judgment.

Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

Works with high quality and compliance mindset.

Capable of managing complex issues, solution-oriented approach.

Ability to perform root cause analysis and implement preventative and corrective action.

Behavioural Competency Expectations

Effective time management, organizational and interpersonal skills, conflict management

Able to work with other experienced research professions to develop skills 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, with support from Line Manager.

Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

Demonstrates commitment to Customer focus.

Positive mindset, growth mindset, capable of working independently and being self-driven.

Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Requirements

B.A./B.S. required with strong emphasis in science and/or biology.

Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

Required Skills

Accountability, Accountability, Adverse Event Report, Clinical Evaluation Reports, Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Communication Sciences, Data Analysis, Detail-Oriented, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Investigations Training, Key Stakeholder Relationships, On Site Monitoring, Problem Solving, Protocol Adherence, Regulatory Compliance, Research Protocols, Root Cause Analysi