Senior Clinical Research Associate

at  ClinChoice

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Clinical Research Associate on a permanent basis. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.
Join our team and help us deliver clinical trials that will improve patients’ lives.

EDUCATION AND EXPERIENCE:

• University Degree in scientific medical or paramedical disciplines
• Previous proven experience as a CRA, performing on-site monitoring activities
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements

MAIN JOB TASKS AND RESPONSIBILITIES:

• Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned
• Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites.
• May act as Feasibility Associate after appropriate and documented training.
• Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance
• Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP’s and ICH-GCP requirements in order to ensure data integrity and subject safety.
• Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data.
• Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site.
• Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues.
• Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project.
• You will be the main contact person for the site in order to ensure close follow up.
• Provides general support to the Clinical Research Division on quality control of clinical data.
• Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned.
• Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial.
• Develops training material and gives training in collaboration with the Training & Qualification Management Unit.
• May assist in contract negotiation with sites on study budget after appropriate and documented training.
• Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites.
• May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.

SPECIFIC ROLE REQUIREMENTS AND SKILLS:

• Fluent in English and German
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel

The Benefits of Working for TalentSource in Germany:

• 30 Euro net Internet cost reimbursement per month
• Additional Accident Insurance, fully covered by the company
• 25 vacation days (but up to 30 days, depending on negotiation)
• Possibility of salary conversion for additional pension insurance
• Dedicated Line Manager
• Monthly meetings with the line manager
• Full performance and development process with end-of-year reviews
• Team events and end-of-year party
• Employee satisfaction survey - your feedback is important for continuous improvement