Job Description

Essential Functions

 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 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 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.

 Contributes to the project team by assisting in preparation of project

publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter

creation, lead CRA team calls etc).

 Facilitates effective communication between investigative sites, the client

company and the PPD project team through written, oral and/or electronic

contacts.

 Responds to company, client and applicable regulatory

requirements/audits/inspections.

 Maintains & completes administrative tasks such as expense reports and

timesheets in a timely manner.

 Contributes to other project work and initiatives for process improvement, as

required.

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.