Location: Germany - home/office based
Schedule: Freelance, Various FTEs
CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Trial Assistant I, you will be working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Job Tasks and Responsibilities:
- Cooperates with the project team with accurately updating and maintaining clinical tracking systems
- He/she is responsible for the preparation, handling, distribution, collection, filing, and archiving of clinical documentation and reports according to the scope of work and the SOPs
- Keeps him/herself professionally abreast of all regulatory and operative aspects relevant to the clinical projects he/she will be assigned
- May act as Feasibility Associate (FEA) after appropriate and documented training
- Should be knowledgeable, following appropriate training, in the application process for clinical studies, in force in the country (ies) of work. Accordingly, he/she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant
- Prepares and requests the necessary local authorities' approvals
- May support the project team in managing the agreements with hospitals and investigational centers
- Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project)
- Assists with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow
- Collaborates with the project team in organizing Investigator and Monitor Meetings
- Manages the telephone monitoring of projects
- Collaborates with the project team in managing the payments of sites
- Collaborates in complying with and enforcing Company procedures
Education and Experience:
- High School Diploma
- Up to three (3) years of Clinical Research experience in the CRO/Pharmaceutical industry
- Good Knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements
- Knowledge of English and local language(s)
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)
The Application Process
Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.
If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.
Who will you be working for?
About CROMSOURCE
CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Clinical Trial Assistant, Assistant, ICH_GCP, English, Clinical Trials, CRO, Clinical Research Organizatio