Sr Cra

Senior CRA - Dedicated to Early Phase studies in New Zealand (Auckland or Christchurch based only)

**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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. 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.

**Job Description**:
Summarized Purpose: Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on
- Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using 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 to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being

followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. 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
- Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Project Manager.
- Contributes to the mentorship, training and development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
- Provides trial status tracking and progress update reports to the Project Manager as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
- 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, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines, SIV Training slides)
- Collaborates directly with the project manager throughout the conduct of the study in relation to site management and monitoring.
- May provide input into preparation of forecast estimates for clinical activities.

Education and Experience:
Bachelor''s degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Clinical research monitoring experience particularly in Early Phase (Healthy volunteer