Freelance Senior Clinical Research Associate

ClinChoice; Deutschland; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A global full-service CRO is looking for a Senior Clinical Research Associate to support a pharmaceutical partner during an FDA inspection in Germany. The role involves ensuring documentation completeness, reviewing IMP documentation, and keeping updated on scientific and regulatory aspects. Candidates need a relevant university degree, strong knowledge of clinical study design, and experience with FDA inspections preferred. This role offers an opportunity to work directly with clients while being part of a supportive culture.

Qualifikationen

• University Degree in a scientific, pharmacy, or other health-related discipline.
• Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines.
• Experience with FDA inspection preferred.

Aufgaben

• Responsible for checking the completeness of the Investigator Site File (ISF).
• Review IMP documentation for accuracy and completeness.
• Stay updated on all scientific, regulatory, and operational aspects relevant to the clinical project.

Kenntnisse

Strong knowledge of clinical study design

Clinical trial operations

GCP/ICH Guidelines

Proficiency in Microsoft Office

Willingness to travel

Ausbildung

University Degree in a scientific, pharmacy, or health-related discipline

Jobbeschreibung

Freelance Senior Clinical Research Associate

Germany

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Clinical Research Associate to work with one of our pharmaceutical partners, to support during an FDA inspection in Germany.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high‑trust environment with the client counter‑parts.

Main Job Tasks and Responsibilities:

• The CRA will be responsible for checking the completeness of the Investigator Site File (ISF), ensuring the study binder and regulatory sections are finalized, and verifying that all essential documents are present.
• Reviewing IMP documentation for accuracy, confirming evidence of PI oversight, and performing an overall completeness check of site documentation.
• Keeping professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical project assigned.

Education, Experience and Skills:

• University Degree in a scientific, pharmacy, or other health‑related discipline, or equivalent.
• Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
• Knowledge of planning tools and planning principles.
• Knowledge of the clinical research process from Phase II/III through final regulatory submission.
• Experience with diabetics and FDA inspection preferred.
• Prior experience with electronic data capture preferred.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
• Willingness to travel.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

ClinChoice has over 28 years of proven high‑quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia‑Pacific.

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. Close management and training is the core instrument to develop and maintain highly‑qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below‑industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self‑employed, Site Management, Monitor, Monitoring, Diabetics, FDA Inspection, Ethics, Contract Research Organisation, CRO