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Study Coordinator/Studienkoordinator

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Leipzig

AI generated summary

  • You must be fluent in German and English, skilled in time management and multitasking, proficient in MS Office, and have strong attention to detail.
  • You will coordinate study compliance, manage data entry, maintain trackers, ensure protocol adherence, QC reports, assist with monitoring visits, report quality issues, and prepare regulatory documents.

Requirements

  • Fluent in German and English
  • Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
  • Appropriate MS Office Skills
  • Good attention to detail

Responsibilities

  • Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies.
  • Ensures accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data.
  • Maintains ISF and study trackers as delegated.
  • Follows the QC process and checks that ICF’s are correctly completed.
  • Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
  • QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
  • Assist with archiving procedures if required.
  • Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
  • Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses.
  • Prepares and collates regulatory documents for submission.
  • Interprets and adheres to company SOP and COP, and assists with input during the review process.
  • Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
  • Assists with drafting compliance reports.

FAQs

What is the work schedule for the Study Coordinator position?

The work schedule is standard, Monday to Friday.

What qualifications are required for this role?

Candidates must be fluent in German and English, have good time management and multitasking skills, appropriate MS Office skills, and good attention to detail.

Where is the clinical site located for this position?

The clinical site for this position is located in Leipzig, Germany.

What are the primary responsibilities of the Study Coordinator?

The primary responsibilities include coordinating operational compliance activities, ensuring accurate data entry, maintaining study trackers, following quality control processes, and assisting with regulatory document preparation among other duties.

Is previous experience in data entry or quality compliance required?

Yes, a background in data entry and quality compliance is preferred for this role.

Does Thermo Fisher Scientific promote diversity and inclusion?

Yes, Thermo Fisher Scientific is an inclusive employer and values diverse experiences, backgrounds, and perspectives.

Are there opportunities for career development at Thermo Fisher Scientific?

Yes, the company provides resources needed to achieve individual career goals and supports personal development through various initiatives.

What regulatory guidelines does the Study Coordinator need to adhere to?

The Study Coordinator must adhere to ICH, GCP, and other regulatory and ethical guidelines and data protection regulations.

Will the Study Coordinator assist with monitoring visits?

Yes, the Study Coordinator will assist monitors and sponsor representatives with preparation and query resolutions during monitoring visits.

Does the position require archiving procedures?

Yes, the Study Coordinator may assist with archiving procedures as needed.

The business community for LGBTQ+ professionals, graduates, inclusive employers and advocates for workplace equality.

Technology
Industry
11-50
Employees
2014
Founded Year

Mission & Purpose

myGwork is the largest global platform for the LGBTQ+ business community. Our mission is to make the workplace more inclusive for all by providing individual users and partner organizations access to a wide eco-system of services, including job opportunities, training, mentoring, employer branding, and free community events. Joining the platform is free for individual members, which supports myGwork’s goal of ensuring that the platform's benefits are as accessible and as far-reaching as possible. Corporate members get a tailored service, with carefully curated product packages to help them achieve all their DE&I goals. myGwork organizes two annual events, WorkFair – the largest virtual global career fair for the LGBTQ+ professionals, graduates and students, and WorkPride – a week-long global conference for the LGBTQ+ business community and allies during Pride Month. The company also recently launched the myGwork Academy, delivering practical and relevant LGBTQ+ training education to help create inclusive workplaces for all.