Clinical Research Associate

Join Our Team asa Clinical ResearchAssociate

TFS HealthScience is aleading global midsize Contract Research Organization (CRO) thatpartners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey.

Our expertise includesfull servicecapabilities resourcing and Functional Service (FSP)solutions.

Aboutthis role

The Clinical ResearchAssociate is responsible fortheinitiation onsite and remote monitoring and termination ofinvestigative sites during study conduct according to companypolicies SOPs and regulatory requirements.

The CRA may conduct allstages of site monitoring (feasibility prestudy initiation interimand closeout).

As part of our SRS team you will be dedicated to onesponsor a global pharmaceutical company and focus onOphthalmology.

Thisis a part time position for around 35 hours permonth.

KeyResponsibilities :

• Monitoronsite and remotely clinical trials in accordance with TFS and / orclient company
• Standard Operating ProceduresFDA regulations and GCP and ICHguidelines
• Review CRFs (paper or electronic)and subject source documentation for validity and accuracy andgenerate queries to investigational sites / clients to resolveproblem data
• Identify siteproblems / deficiencies and bring to the attention of managementthrough trip reporting memos and verbal communication with ProjectManager or Lead CRA
• Initiates corrective actionto resolve issues as directed bysupervisor
• Contribute to the completion of theapplication to Ethics Committee / IRB prepare necessary documentationenclosed to the application according to local requirements incooperation with CTA and directed by Lead CRA / ProjectManager
• Participate in contract handling andnegotiation directed by Lead CRA / ProjectManager
• Set up ISF and SMF (or cooperate withCTA) and distribute to the investigationalsites.
• In cooperation with study teamresponsible for SMFmaintenance

Qualifications :

• BachelorsDegree preferably in life science or nursing; orequivalent
• Minimum 13 years of relevantclinical experience
• Able to work in a fastpaced environment with changingpriorities
• Understand basic medical terminologyand science associated with the assigned drugs and therapeuticareas
• Possess the understanding of GoodClinical Practice regulations ICHguideline

WhatWe Offer

We provide a competitivecompensation package comprehensive benefits and the opportunity forpersonal and professional growth in a rewarding environment.

Youllbe joining a team that values collaboration innovation and making adifference in the lives ofpatients

A Bit More AboutUs

Our journey began over 27 yearsago in Sweden in the city of Lund. As a fullservice global ContractResearch Organization (CRO) we build solutiondriven teams workingtowards a healthier future.

Bringing together over 800professionals TFS delivers tailored clinical research services inmore than 40 countries with flexible clinical development andstrategic resourcing solutions across key therapeutic areasincluding Dermatology Neuroscience Oncology andOphthalmology.

Our cores values of Trust QualityPassion Flexibility and Sustainability are our guiding lightserving as the framework for decisionmaking at all levels of theorganization.

They assist us in attracting and retaining valuabletalent who share our sentiments resulting in high employeeengagement and satisfaction.

By aligning on these fundamentalvalues we cultivate a unifed force geared towards innovation andexcellence. This collective effort propels us towards our sharedgoal and fosters a culture of mutual respect and collaboration.

Together we make adifference