For one of our clients, we are looking for a Freelance CRA to come on board and join the team. This position is open for Freelance German speaking consultants with medical device experience who would have 0.7 to 1 FTE availability to give them support in managing sites in Germany, Switzerland and Austria. Remote opportunity + Up to 80% travel is possible.
Job Description
As a CRA you will be responsible for managing clinical activities at study sites conducting studies for Medical Devices. You will perform site management and monitoring activities and act as the main line of communication with the participating sites. Your focus will be on the DACH region (Germany, Switzerland and Austria).
Responsibilities
- Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
- Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
- May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
- Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
- Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
- Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
- Performs study-related training.
- Manages the development and maintenance of study documents, processes and systems as assigned.
- Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
- Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
- Attends internal and external meetings as required.
- Provides all job-related progress reports and visit documentation as required.
- May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
- Prepares and coordinates submissions to regulatory authorities.
- May perform other activities as assigned.
Requirements
- Higher education degree or equivalent education, training, and experience.
- +2 year's experience as a Clinical Research Associate
- Experience in monitoring medical device studies.
- Fluency in English and German.
- Understanding of clinical research processes and regulations.
- Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.
Contract information
- Freelance role
- 1 year contract to start with (+ possible extension)
- 0.7 FTE to full-time
- Remote working + 80% of travel in Germany, Austria and Switzerland.
