Associate Clinical Research Associate

5 months ago

Toronto, Canada Merck Sharp & Dohme Full time

**Associate Clinical Research Associate (Toronto)**
We are currently recruiting three positions in Toronto.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

With support of Senior 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.

**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 International Conference on Harmonisation Good Clinical Practice, Sponsor Standard Operating Procedures, 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.
- 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 Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Associate Manager, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed.
- Works in partnership with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Head Quarters functional areas and externally with vendors and Institutional Review Board/Institutional Review Committee and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Performs co-monitoring where appropriate.

**Competency Expectations**:

- Fluent in 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 International Conference on Harmonisation Good Clinical Practice & 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, solution-oriented approach.
- Ability to perform root cause analysis and implement preventative and corrective action.

**Behavioral 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 self driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

**Education**:

- B.A./B.S. required with strong emphasis in science and/or biology.
- M in. 2 years of clinical research experience. Related Clinical Research experience may include Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar.

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