MSD Clinical Research Associate 

Colombia 

389980335

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 the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

•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.

•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.

•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.

Extent of Travel

CORE Competency Expectations:

•Fluent in Local Languages and 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 & country clinical research law & guidelines. •Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. •Hands on knowledge of Good Documentation Practices

•Proven Skills in Site Management including 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

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:

Required:Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements:

Preferred: •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.

Job Posting End Date:07/05/2024

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.