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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 versatile 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 T

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