Clinical Research Associate

hace 2 semanas

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo
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.


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 indepth understanding of the study protocol and related procedures.
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive and accurate visit & nonvisit 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

Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

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
  • 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

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/28/2024

Job Posting End Date:
06/28/2024

Requisition ID:
R299352

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