Ref #: 37090
Employment type: Permanent - Full-Time
Location: home based in Germany
Posted: 24-Jun-2022
Description
Roles & Responsibilities of the position:
The Clinical Research Associate will be responsible for monitoring local clinical studies in Germany and is the primary contact point between the sponsor and the investigational sites.
A successful candidate is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
Key Responsibilities:
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
#CRAjob
The Clinical Research Associate will be responsible for monitoring local clinical studies in Germany and is the primary contact point between the sponsor and the investigational sites.
A successful candidate is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
Key Responsibilities:
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
#CRAjob