Clinical Trial Associate-Clinical Project Assistant Job in Office Based Solution
Clinical Trial Associate-Clinical Project Assistant
We need a CTA or SCTA
The position will be office-based in one of our offices in Germany (Neu-Isenburg, Freiburg/Br. or München-Sauerlach).
PURPOSE
Provide administrative support to clinical projects with minimal supervision from line manager, Clinical Team Leads and/or other designated clinical team members. May assist with general administrative functions as required.
RESPONSIBILITIES
Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
May perform assigned administrative tasks to support team members with clinical trial execution.
Qualifications:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Ideally knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Strong written and verbal communication skills including good command of German and English language.
Effective time management and organizational skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience
Primary Location: DEU-Hessen-Neu-Isenburg
Other Locations: DEU-Bayern-München-Sauerlach, DEU-Baden-Württemberg-Freiburg
For further inquiries and information please contact Sean Sutton Progressive Munich S-Three