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About the Role

As a Clinical Research Associate (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure trial adherence to guidelines and SOPs. Your role is crucial in guaranteeing subjects' rights, well-being, and data reliability, while maintaining audit readiness and fostering collaborative relationships with investigational sites.

Responsibilities

Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis to identify site process failures and implement corrective/preventive actions.
Ensure data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters in a timely manner using approved business writing standards.
Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process.
Ensure shared responsibility with other project team members on issues/findings resolution.
Investigate and follow-up on findings as applicable.
Participate in investigator meetings as necessary.
Identify potential investigators in collaboration with the client company.
Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory obligations.
Perform trial close-out and retrieval of trial materials.
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
Conduct on-site file reviews as per project specifications.
Provide trial status tracking and progress update reports to the Clinical Team Manager.
Ensure study systems are updated per agreed study conventions.
Facilitate effective communication between investigative sites, the client company, and the PPD project team.
Respond to company, client, and applicable regulatory requirements/audits/inspections.
Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.
Assist in the preparation of project publications/tools and share ideas/suggestions with team members.
Contribute to other project work and initiatives for process improvement, as required.

Requirements

Bilingual in French is required - can be located in QC/ON
Alzheimer's experience is required
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid driver's license where applicable.
An equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Skills

Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through good listening skills, attention to detail, and the ability to perceive customers’ underlying issues
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills

Location

Office

Work Type

Standard (Mon-Fri)
Office
Remote
On-site

Experience Level

Level II
1 year as a clinical research monitor

Education Level

Bachelor's degree in a life sciences related field
Registered Nursing certification
Equivalent and relevant formal academic / vocational qualification

About the Company

Successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.