Job Description

　　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 pplicable

　　 Provides updates on potential trends noted across multiple sites and discusses

　　potential strategies for their management to the Clinical Team Manager (CTM).

　　 Supports Clinical Team Management, including or Clinical Manager of CRAs (CMCRA), to mentor, train and contribute to the 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 Clinical Team

　　Manager (CTM) 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

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