Clinical Research Associate (m/f/d)

TFS HealthScience

2d•Remote

About The Position

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 a Clinical Research Associate - home based in Germany (Hamburg area preferred). As part of our CDS Oncology and Dermatology teams you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The 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 out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.

Requirements

Bachelor’s Degree, preferably in life science or nursing; or equivalent
Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities
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.
Strong written and verbal communication skills.
Fluent in English and German
Excellent organizational skills
Technology savvy and good software and computer skills

Nice To Haves

Soft skills: Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail
Ability and willingness to travel up to 60-80%, overnight and abroad if applicable.

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.
Participate in audit and/or inspection, its preparation and follow-up 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