Associate Clinical Research Associate

hace 2 semanas

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

Job Description:


With support of Sr Clinical Research Associate/Clinical Research Associate and/or Clinical Research Associate 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 Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gains an indepth 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 onsite monitoring & oversight activities using various tools to ensure:
  • Data generated at site are complete, accurate and unbiased
  • Subjects' right, safety and wellbeing are protected
  • 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.
  • Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
  • 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 Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Associate Manager, Clinical Research Manager, Therapeutic Area Head and Clinical Director as needed.
  • Works in partnership with Global Clinical Trials Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Head Quarters functional areas and externally with vendors and Institutional Review Board / Institutional Ethics Committee and Regulatory Authorities in support of assigned sites
  • Manages and maintains information and documentation in Clinical Trial Management System and various other systems as appropriate and per timelines.
  • Supports audit/inspection activities as needed.
  • Performs comonitoring 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 Clinical Research Associate 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.
  • Works with high quality and compliance mindset.
  • Capable of managing complex issues, solutionoriented 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 selfdriven.
  • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
B.A./B.S. required with strong emphasis in science and/or biology.
Min. 2 years of clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R244580

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