Clinical Research Associate I

Clinical Monitoring Darmstadt, Germany


Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

We’re looking for a talented
and energetic CRA I to join our team in Germany! Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact.

You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
 

As a CRA at Premier Research, you’ll have the opportunity to monitor in diverse therapeutic areas and contribute your monitoring expertise and knowledge to move Premier Research into the future. You’ll perform the management of study site activities to ensure the collection of accurate clinical data within given timelines. You’ll proactively identify, resolve/mitigate and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support. 

We are looking for a CRA I with onsite experience, especially within Medical Device or Oncology.  Dermatology experience can be considered as well.

What you’ll be doing:

  • Monitor data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety. Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
  • Schedule and plan day-to-day activities for study monitoring and setting priorities by site. Maintain contact with investigator sites via telephone calls between visits.
  • Gauge the quality of clinical deliverables and addressing quality issues with team members.
  • Deliver high-quality, timely monitoring reports for sponsor approval per Monitoring Plan timelines.
  • Work with your Line Manager and Clinical Lead to ensure that visit metrics are maintained.
  • Participate in Investigators’ Meetings as assigned by Project Managers.
  • Ensure adherence to study timelines and budgets.
  • Manage query resolution with study sites and Premier Research data management operations. Identify and escalate potential risks and possible retraining opportunities for site study teams.
  • Participate in training offered to increase therapeutic knowledge and keep current with regulations and local requirements.

You’ll need this to be considered:

  • Bachelor’s Degree or equivalent experience required along with a minimum of 1 year of on-site monitoring experience with all types of site visits
  • Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
  • Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team.
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.
  • Ability to travel up to 75%
  • Fluency in written and verbal German and English is mandatory. Any other language is a bonus.
  • Valid driver’s license, passport as required

This will be a permanent role in Germany. Experience at working on Medical Device, Oncology, Dermatology clinical trials is preferred. 

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