Clinical Research Associate II

Performing monitoring visits according to plan, document actions and follow up on action plans Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators
and accountability for patient recruitment strategies
Train and guide site staff in the protocol and trial procedures to minimize protocol deviations(PDs)
Train site staff in safety information handling and systems
Know and meet all local and company requirements with respect to safety reporting
Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
Identify potential risks and proactively take action to prevent or mitigate
Collaborate with Data Management/logistics in resolving queries
Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
Manage trial product requirements, incl. temperature deviations and training of site staff
Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
Ensure collaboration with and deliverables from vendors locally, if applicable
Collection and management of essential documents
Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable

Minimum of 3+ years on site CRA experience to include different visit types, SEV, SIV, MV, COV.
Willing to mentor and train junior colleagues on monitoring principles and activities
Ability to interpret data and review for reporting trends: Eg: SAEs, IPDs and Drug Dosing Deviations etc.
Demonstrate good knowledge and appropriate understanding of inspection readiness
Ability to identify root cause of issues clearly
Ability to identify corrective and preventative actions to issues or findings
Understand and explain trial endpoints
Ability to support CTM with vendor related issues
Sc. or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region
Ideally experience from a similar position in the pharmaceutical industry or Clinical Research
Organization (CRO). Other experience may also be relevant, e.g. as study staff at a clinical research site.
Ability to build and maintain relationships with sites

Clinical Trial Administrator