FSP CRA (Level II)

At Thermo Fisher Scientificyoulldiscover 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 healthiercleanerand safer. We provide our teams with the resources needed to achieve individual career goals while taking science a stepbeyond throughresearchdevelopmentand 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.

Summarized Purpose:

Performs and coordinatesdifferent aspectsof the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e.FSO FSP Government etc.). Acts as a site processes specialist ensuring that the trial is conductedin accordance withthe approved protocol ICH-GCP guidelines applicableregulationsand SOPs to guarantee subjects rightswell-beingand data reliability.Ensuresaudit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned toroleare outlined in the task matrix.

Key responsibilities

• Monitors investigator sites with a risk-based monitoringapproach:applies root cause analysis (RCA) criticalthinkingand problem-solving skills toidentifysite processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDRSDVand CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.Documentsobservations in reports and lettersin a timely mannerusing approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need tomaintainregular contact between monitoring visits with investigative sites to confirm that the protocol is being followed that previouslyidentifiedissues are being resolved and that the data is being recordedin a timely manner. Conducts supervising tasksin accordance withthe approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates andfollows-up on findings as applicable.

• Participatesin investigator meetingsasvital.Identifiespotential 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 wherewarranted. Performs trial close out and retrieval of trial materials.

• Ensures thatcrucial documents are complete and in place according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as. Ensures study systems are updated per agreed study conventions (e.g.Clinical Trial Management System).

• Facilitates effective communication between investigative sites the clientcompanyand the PPD project team through writtenoraland/or electronic contacts.

• Responds to companyclientand applicable regulatory requirements/audits/inspections.

• Maintains& completesadministrative tasks such as expense reports and timesheetsin a timely manner.

• Contributes to the project team by assisting in preparation of project publications/tools andsharing ideas/suggestions with team members.

• Contributes to other project work and initiatives for process improvement as.

Keys to Success

Education and Experience:

Bachelors degree in alife sciencesrelatedfieldera Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previousexperience that provides the knowledge skills and abilities to perform the job (comparable to 1yearsas a clinical research monitor) or completion ofPPDDrug Development Fellowship. Valid driverslicense whereapplicable.

KnowledgeSkillsand Abilities:

• Proven clinical monitoring skills.

• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

• Demonstrated ability toattainand maintain a solid understanding of ICH GCPs applicableregulationsand procedural documents.

• Well-developed critical thinking skills including but not limitedto:critical mindset in-depth investigation forappropriate rootcause 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 tomaintaincustomer focus through theutilizationof good listening skills attention todetailand the ability to perceive customers underlying issues.

• Good organizational and time management skills

• Effective interpersonal skills.

• Attention to detail.

• Ability to remain flexible and adaptable in a wide range of scenarios.

• Ability to work in a team or independently as.

• Good digital literacy: solid knowledge of Microsoft Office and the ability to learnappropriate software.

• Good English language and grammar skills.

• Good presentation skills.

Benefits

We offer competitiveremuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Our Mission is to enable our customers to make the world healthiercleanerand safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technologicalinnovationand support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis ofrace color religion sex sexual orientation gender identity national origin protected veteran statusdisabilityor any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibilityservicefor job seekers requiringaccommodationsin the job application process. For example this may include individualsrequiringassistancebecause of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability orassistinga person with a disability and require accessibilityassistanceoran accommodationto apply for one of our jobs pleasesubmita request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.