Assistant CRA, m/f/d

This is a fully remote position, open to applicants in Germany.

📋 Description

• Execute remote site management and monitoring activities for assigned project(s).

• Reach out to study sites to gather necessary documentation, address issues, and request any outstanding information.

• Establish and maintain open and collaborative communication with site staff.

• Engage in discussions regarding protocol execution, enrollment rates and strategies, ongoing issues, EDC completion, and queries.

• Complete, track, and follow up on ETRTR for subject data available in the EDC.

• Review study logs remotely as required.

• Conduct and document site management calls/contacts.

• Investigate and follow up on findings from centralized monitoring.

• Assess PI oversight, subject safety, and study processes.

• Perform remote investigations into site performance using a risk-based monitoring approach.

• Provide refresher training and follow up on any outstanding administrative needs.

• Review ad-hoc clinical listings, tracking and analyzing violations and deviations.

⛳️ Requirements

• Bachelor’s Degree in a field related to life sciences.

• Prior clinical research experience of 0-1 year.

• Knowledge of clinical monitoring gained through coursework or training.

• Basic understanding of medical/therapeutic areas.

• Familiarity with medical terminology.

• Capability to attain and maintain a working knowledge of ICH GCPs.

• Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP).

• Ability to successfully finish the RSM Onboarding Workshop.

• Fluency in both German and English (minimum C1 Level).

• Ability to evaluate medical research data.

• Strong oral and written communication skills.

• Good organizational and time management abilities.

• Exceptional attention to detail.

• Capacity to work effectively in a team or independently.

• Well-developed critical thinking skills.

• Competent computer skills with proficiency in MS Office.

🏝️ Benefits

• Opportunities for continued career advancement.

• Award-winning training programs.

• Benefits that focus on the health and wellbeing of our employees.

• A flexible working culture.