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Job Overview

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

About the Role: Clinical Research Associate (Level II)

• Position: Clinical Research Associate (Level II)
• Location: Remote
• Industry: Clinical Research / Life Sciences

What You’ll Do

• Monitors investigator sites with a risk‑based monitoring approach: applies root cause analysis (RCA), critical thinking and problem‑solving skills to identify site processes failure and corrective/preventive actions.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on‑site and remote monitoring activities.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Performs monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution; investigates and follows‑up on findings as applicable.
• Participates in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
• 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 (e.g. Clinical Trial Management System).
• 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.

Education

• Bachelor’s degree in a life sciences related field or a Registered Nursing certification or equivalent.
• Valid driver’s licence where applicable.

Experience

• 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.
• In some cases 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.

Knowledge, Skills, Abilities

• 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. Includes but not limited to: 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 the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
• Good organisational 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.

Benefits

• Health & Wellbeing: comprehensive benefits, wellness programs, Employee Assistance Program providing confidential support.
• Flexibility: balance your work and personal life.
• Extra Leave: generous leave policies, option to purchase additional leave, paid birthday leave, company paid parental leave.
• Charitable Giving & Volunteering: paid volunteer time to support non‑profit organisations.
• Learning & Development: online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, mentorship programmes.

Equal Employment Opportunity

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule

Standard (Mon‑Fri)

Environmental Conditions

Office

Company Culture

Thermo Fisher Scientific’s Mission is to enable our customers to make the world healthier, cleaner and safer. Watch (as our colleagues explain 5 reasons to work with us). We value integrity, intensity, innovation and involvement and are committed to a diverse culture that rewards high performance and nurtures talent.

Recruiter / Agency Closing

At ICON Strategic Solutions, you will work in a sponsor‑dedicated model, supported by ICON's global expertise. We offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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