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Senior Clinical Research Associate at ClinSmart

Berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

30 Dec, 26

Salary

50000.0

Posted On

01 Oct, 26

Experience

14 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Pharmaceutical Manufacturing

Description

Organization, coordination and monitoring of clinical trials in accordance with ICH and GCP guidelines as well as internal SOPs.
Recruitment, selection and training of investigators and study centers
Conducting study initiation, routine monitoring (on-site / remote) and final visits at study centers throughout Germany, including center communication and written documentation.
Identifying problems on site and escalating them to the study sponsor
Conceptualization and submission of documents to ethics committees and federal authorities, as well as support with correspondence.
Deadline and deadline monitoring
Maintaining study data in databases (Access, Excel)
Support with submission activities / Management of the TMF

qualification

At least 1 year of experience as a clinical monitor
Very good knowledge of ICH-GCP and AMG
Very good PC user skills (MS Office)
Good English skills, both spoken and written.
Excellent organizational skills, independence, flexibility, reliability, strong team spirit, communication skills and open-mindedness.
Ideally, knowledge in the field of monitoring oncological studies.

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Responsibilities

Organization, coordination and monitoring of clinical trials in accordance with ICH and GCP guidelines as well as internal SOPs.
Recruitment, selection and training of investigators and study centers
Conducting study initiation, routine monitoring (on-site / remote) and final visits at study centers throughout Germany, including center communication and written documentation.
Identifying problems on site and escalating them to the study sponsor
Conceptualization and submission of documents to ethics committees and federal authorities, as well as support with correspondence.
Deadline and deadline monitoring
Maintaining study data in databases (Access, Excel)
Support with submission activities / Management of the TMF

At least 1 year of experience as a clinical monitor
Very good knowledge of ICH-GCP and AMG
Very good PC user skills (MS Office)
Good English skills, both spoken and written.
Excellent organizational skills, independence, flexibility, reliability, strong team spirit, communication skills and open-mindedness.
Ideally, knowledge in the field of monitoring oncological studies.