Experienced CRA (CRA II, Sr. CRA & Principal CRA) - Ontario, Canada

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Ensures audit readiness. Develops collaborative relationships with investigational sites.

A day in the Life:

• Monitors investigator sites with a risk-based monitoring approach.
• Ensures data accuracy through SDR, SDV and CRF review.
• Assess investigational products through physical inventory and records review.
• Escalates observed deficiencies and issues to clinical management expeditiously.
• May need to maintain regular contact between monitoring visits with investigative sites.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Participates in investigator meetings as necessary.
• Initiates clinical trial sites according to the relevant procedures.
• Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensures study systems are updated per agreed study conventions.
• Facilitates effective communication between investigative sites, the client company and the PPD project team.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets.
• Contributes to the project team by assisting in preparation of project publications/tools.
• Contributes to other project work and initiatives for process improvement.
• Job Complexity Works on problems of limited scope.
• Job Knowledge Learns to use professional concepts.
• Supervision Received Normally receives detailed instructions on all work.
• Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department.

Keys to Success:

Education

• Bachelor's degree in life related field or a Registered Nursing certification or equivalent.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor).
• Valid driver's license where applicable.
• In some cases, an equivalency will be considered sufficient.

Knowledge, Skills, Abilities

• Proven clinical monitoring skills.
• Demonstrated understanding of medical/therapeutic area knowledge.
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs.
• Well-developed critical thinking skills.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Good computer skills.
• Good presentation skills.

Work Environment

• Able to communicate with diverse groups of people.
• Able to work upright and stationary for typical working hours.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology.
• Able to perform successfully under pressure.
• May have exposure to potentially hazardous elements.
• This role requires independent travel up to 80%.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process.