Senior Clinical Research Associate

About this role

TFSHealthScience is a leading global midsize Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservicecapabilities resourcing and functional service (FSP) solutions.

The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS Health Science and will function operationally as a member of a Project Team and is responsible for the initiation onsite and/or remote monitoring close out of study sites during study conduct according to company policies SOPs and GCP and ICH guidelines and other regulatory requirements

Key Responsibilities

Monitor onsite and remotely clinical trials in accordance with TFS and/or sponsor Standard

Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.

Perform all required monitoring activities at the study sites to assess and ensure subjectssafety data integrity and quality.

Verify the protection of study participants by informed consent procedures and protocolrequirements that follow appropriate regulations.

Review CRFs (electronic or paper) and subject source documentation for validity and accuracy

Verify proper management and accountability of Investigational Product.

Timely reporting of actions taken during monitoring visits in Monitoring Visit Report includingfindings corrective and preventive actions already taken and update applicable trackingsystems as required; escalate observed deficiencies and issues as appropriate.

Providing site with the listing of issues identified during monitoring visit and action items whichwill need to be addressed in a timely manner.

Timely delivering site documents to eTMF or paper TMF; verify that the Investigators Site File(ISF) is maintained in accordance with GCP and ICH guidelines and local regulatoryrequirements.

Participate in audit and/or inspection its preparation and followup activities as needed.

Order ship and reconcile clinical investigative supplies for study sites if applicable

Update CTMS and all other required by projects systems with accurate site level information

Qualifications

Bachelors Degree preferably in life science or nursing; or equivalent

Over 45 year of relevant clinical experience or relevant academic background around clinical trialor clinical development activities

Able to work in a fastpaced environment with changing priorities.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.