Senior Clinical Research Associate (m/f/d)

TFS; Hamburg; Remote; EUR 70,000 - 95,000; Full time

Job summary

TFS HealthScience is seeking a Senior Clinical Research Associate to support Dermatology, Immunology & Inflammatory Diseases studies from home in Germany (Hamburg area preferred). The role involves initiation, on-site and remote monitoring, and study close-out in line with GCP, ICH guidelines and SOPs.

You will work within the CDS DIID team to ensure patient safety, data integrity and regulatory compliance while collaborating with project teams.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• >3 years of CRA experience including on-site monitoring.
• Able to work in a fast-paced environment with changing priorities.
• Understand medical terminology and science related to the drugs/therapeutic areas.
• Knowledge of GCP and ICH guidelines.
• Independent work and strong teamwork capabilities.
• Excellent written and verbal communication skills in English and German.
• Strong organizational skills and technical proficiency.
• Soft skills: proactive, collaborative, analytical, and detail-oriented.

Responsibilities

• Monitor on-site and remote clinical trials per SOPs, GCP, ICH and regulations to safeguard subjects and data quality.
• Verify informed consent procedures and protocol adherence.
• Review CRFs and source documentation for validity and accuracy.
• Verify Investigational Product management and accountability.
• Timely reporting of monitoring actions and CAPAs in reports and tracking systems.
• Provide site with issues list and action items; ensure timely resolution.
• Deliver site documents to eTMF or paper TMF.
• Ensure ISF maintenance per GCP/ICH and local regulations.
• Update CTMS and project systems with site-level information.
• Participate in audits/inspections and follow-up activities.
• Order, ship, and reconcile clinical supplies for sites if applicable.
• Assist in project tasks: tracking, monitoring plans, monitoring reports review, CRA resource management.
• May perform ASV visits; mentor CRAs; contribute to therapeutic area training and capabilities presentations.

Skills

Fluent in English and German

Excellent written and verbal skills

Excellent organizational skills

Technology savvy and software skills

Independent and team player

Ability to manage complex studies

Education

Bachelor’s Degree in life science or nursing

Job description

Join Our Team as a Senior Clinical Research Associate - home based in Germany (Hamburg area preferred).

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.

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 Associate will 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; elevate 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.

• 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.