Senior Clinical Research Associate

hace 4 semanas

Bogotá, Bogotá D.E., Colombia Merck Gruppe - MSD Sharp & Dohme A tiempo completo
Job Description

The role of Senior Clinical Research Associate 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, policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

As a primary site contact and site manager throughout all phases of a clinical research study, the person takes overall responsibility of allocated sites. Actively developing and expanding the territory for clinical research, finding and developing new sites, the person participates in internal meetings and workstreams as SME for monitoring processes and systems.

Responsibilities include:

  1. Developing strong site relationships and ensuring continuity of site relationships through all phases of the trial.
  2. Performing clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  3. Gaining an in-depth understanding of the study protocol and related procedures.
  4. Coordinating & managing various tasks in collaboration with other sponsor roles to achieve Site Ready.
  5. Participating & providing inputs on site selection and validation activities.
  6. Performing remote and on-site monitoring & oversight activities using various tools to ensure:
  • Data generated at site are complete, accurate and unbiased.
  • Subjects' rights, safety, and well-being are protected.
  • Conducting 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.
  • Collecting, reviewing, and monitoring required regulatory documentation for study start-up, study maintenance, and study close-out.
  • Communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
  • Identifying, assessing, and resolving site performance, quality or compliance problems and escalating per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and if applicable, RCPM.
  • Managing and maintaining information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
  • Contributing strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
  • Supporting and/or leading audit/inspection activities as needed.
  • Following the country strategy defined by CRD and CRA manager, contributing to the identification of new potential sites and working closely with them to develop strong clinical research capabilities.
  • Mentoring/buddying junior CRAs on process/study requirements and performing co-monitoring visits where appropriate.
  • Could perform Quality control visits if delegated by other roles and trained appropriately.

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.
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • 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 analyze 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:

Required:

  • Min. 4 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.

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