Precision for Medicine is looking to fill a Clinical Research Associate II position to manage and monitor clinical research studies in Germany.
Requirements
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
- Experience monitoring EDC trials and EHR records
- Experience in biopharma or relevant therapeutic area
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
- Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
- Knowledge of GCP/local regulations and organizational procedures
- Experience with investigational product (IP) inventory, reconciliation and reviews storage and security
Responsibilities
- Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
- Updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
- Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
- Identifies and processes Serious Adverse Events according to the procedures defined by the study team.
Other
- University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
- 1,5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Excellent communication and organizational skills are essential. A team player.
- Evidence of a client focused approach
- Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
- Fluency in English and for non-English speaking countries the local language of country where position based
