Thermo Fisher Scientific Jobs

Job Description

Job Purpose

This individual ensures that clinical studies are conducted at investigator sites in compliance with:

• the current approved protocol and any protocol amendment(s),

• ICH GCP

• GSK Written Standards

• applicable local laws and regulatory requirement(s)

so that the rights, safety and well-being of human subjects is protected and that the reported study data is accurate, complete, and verifiable from source documents.

Key Responsibilities (10 bullet points maximum)

Describe the key deliverables, specific duties, any specialist duties and the ongoing responsibilities of the role.

• Accountable for all aspects of site management including ensuring completion and delivery of all local activities required for high quality set up, execution and completion of studies to agreed timelines.

• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency (Risk Based Monitoring) and site closeout visits.

• Collaborates with the study teams to conduct study feasibility and site selection. Performs site evaluation visits, determines the feasibility of conducting protocols with reference to study complexity, staff availability, clinical facilities, potential for recruiting patients, site selection and ability to comply with ICH GCP investigator and GSK requirements for clinical studies.

• Works with Local Delivery Lead (LDL) to carry out a local study / site level risk assessment. Assists with audits and inspections.

• Communicates progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders - e.g. CRA Manager / Lead as appropriate.

• Ensures that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.

• Maintains good relationships with site while communicating and implementing patient inclusion / exclusion criteria, study stop/go decisions, timeline changes, early termination of studies and changed status of studies.

• Works with the sites to ensure they address data queries in a timely manner. Ensure Investigator and site staff receive safety reports and new safety information in a timely manner.

• Assists (depending on local practices) with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) and maintain communication with RA and ECs to ensure all regulatory requirements are met in timely manner throughout the study.

• Ensures all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.

• Ensures clinical study activities are conducted in accordance with the clinical trial agreement and related contracts.

• Responsible for maintaining the sponsor files during the life of the study. Assisting with archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.

• Delivers appropriate training to site staff and other relevant parties, as required.

• Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities. May take on role of local expert/champion or subject matter expert in a business system / process.

• Shares best practices within the LOC and with colleagues in other LOCs.

• Acquires and maintains an appropriate level of knowledge on the pathology of disease area being studied, the study compound, the study protocol and all study related activities.

• Attendance at internal project meetings and relevant training courses. Participates continuously in relevant training courses to improve personal / professional skills. Keeps up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions.

• Available and willing to travel as job requires.

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.