Senior Clinical Research Associate (m/f/d)
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as aSenior Clinical Research Associate - home based in Germany (Hamburg area preferred).
About this role
As part of our CDS DIID (Dermatology, Immunology & Inflammatory Diseases)team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Senior Clinical Research Associatewill function operationally as a member of a Project Team and is responsible for the initiation, on–site and/or remote monitoring, close outof study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.
Key Responsibilities:
Monitor on-site 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 subjects safety, data integrity and quality.
Verify the protection of study participants by informed consent procedures and protocol requirements 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 including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
Timely delivering site documents to eTMF or paper TMF.
Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
Update CTMS and all other required by projects systems with accurate site level information
Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
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May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include:
project tracking,
monitoring plans,
review of monitoring reports
CRA resources management within the project
May perform Assessment Site Visits (ASV) when requested.
May act as mentor of CRAs.
May develop and implement therapeutic area training for other CRAs and project team members.
May participate in capabilities presentations.
Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent
>3 years of experience as CRA including relevant on-site monitoring experience.
Able to work in a fast-paced environment with changing priorities.
Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
Ability to work independently as well as in a team matrix organization.
Excellent written and verbal communication skills
Fluent in English and German
Excellent organizational skills
Technology savvy and good software and computer skills
Soft skills requirements: Self-awareness, resolute, flexibility, collaborative mindset, proactivity, analytic approach, and attention to detail, coach ability, motivated to take on new challenges, facilitation of discussion, diplomacy in difficult situations.
Ability to take the ownership of the assigned tasks.
Ability to manage complex or early phases studies.
Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable.
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll 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 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 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 decision-making 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.
Originally posted on Himalayas