Requisition ID: CLI008799
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company : one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The role is accountable for performance and compliance for assigned protocols and sites in Argentina.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck 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 expand 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 and Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in:depth understanding of the study protocol and related procedures.
- Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates and provides inputs on site selection and validation activities.
- Performs remote and on:site monitoring and oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o 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 and 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, and RCPM.
- 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
- 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 capabilitiesQualifications
CORE Competency Expectations:
- Fluent in 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 and country clinical research law and guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guideli
