MSD Clinical Research Associate 

Guatemala, Sacatepéquez, Antigua Guatemala 

795622187

Job Description

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

Under the oversight of the CRA manager, this person ensures compliance of study conduct with ICH/GCP and country regulations, our company 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 siteactivities in compliance with 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:

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 & 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.

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

• 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 appropiately

CORE Competency Expectations:

• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

• 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 a virtual environment.

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills

• 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 mind-set

Experience Requirements:
Desirable: Min. 2 year of direct site management (monitoring) experience in a bio/pharma/CRO.

Required:"· Min. 1 year of experience in clinical research (study coordination).
Educational Requirements:
· B.A./B.S. with strong emphasis in science and/or biology

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.