Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites.
Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
Under close supervision, may perform site selection, start-up / regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and / or line manager.
Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
Gain experience with standard IQVIA tools, metrics and reports.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree or currently enrolled in bachelor's degree program preferably in life science; or equivalent combination of education, training and experience.
Excellent written and verbal skills in English and German language (C1 minimum)
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is preferred.
Basic organizational, interpersonal and problem-solving skills
Strong attention to detail
Working time management skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
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