Job Description

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.

Senior Clinical Research Associate

Location: Calgary, Alberta


The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate Manager or Clinical Research Director, the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.


The Senior Clinical Research Associate acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. They actively develop and expand the territory for clinical research, finding and developing new sites. They will participate in internal meetings and workstreams as the subject matter expert for monitoring processes and systems.

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 the 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 and manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates and provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure:

+ Data generated at site are complete, accurate and unbiased.
+ 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 Clinical Research Associate Escalation Pathway (as appropriate), in collaboration with the Clinical Research Associate Manager, Clinical Research Manager, Therapeutic Area Head and Clinical Research Director as needed. Works in partnership internally with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarters functional areas and externally with vendors and Institutional Review Boards/Institutional Review Committees 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. Contributes strongly to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Supports and/or leads audiUinspection activities as needed. Following the country strategy defined by Clinical Research Director and Clinical Research Associate manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Mentors/ buddies junior Clinical Research Associates on process/study requirements and performs co-monitoring visits where appropriate. Could perform Quality control visits if delegated by other roles and trained appropriately.

Core Competency

Expectations:

Fluent in 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 International Conference on Harmonisation Good Clinical Practice guidelines as well as country clinical research law and guidelines. Excellent understanding of Global, Country and Regional Clinical Research Guidelines and has the 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 Microsoft 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. Experience with conducting site motivational visit designed to boost site enrollment. Capable of managing complex issues, works in a solution-oriented manner. Performs root cause analysis and implements preventative and corrective action. Capable of mentoring junior Clinical Research Associates on process/study requirements and is able to perform co monitoring visits where appropriate.

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. 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.

Experience

Requirements:

Required:

Min. 4 years of direct site management (monitoring) experience in a bio/pharma/Clinical Research Organization.

Preferred:

B.A./B.S. with strong emphasis in science and/or biology.

Travel

:

Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver's license preferred (Must have in certain countries).

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.


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:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/16/2025

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:

R338972