Clinical Research Associate

hace 2 semanas

Bogotá, Colombia MSD A tiempo completo

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall 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 SOPs, 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.
  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM 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.
Experience Required
  • Min. 2 years of direct site monitoring experience in a bio/pharma./CRO.
Note - No compromise on min monitoring experience however specific experience requirements may vary depending on the Country
Educational Requirements
B.A./B.S. preferred with strong emphasis in science and/or biology
Travel Expectations
  • Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.
  • Current driver’s license preferred.
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 analyze 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 mindset

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/4/2024
  • 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.

Requisition ID: R320080

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