Senior Clinical Research Associate Full-time Job

Performing monitoring visits according to plan, document actions and follow up on action plans Site feasibility visits incl. analysis of site logistics, clinical research 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 clinical research 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 clinical research 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,clinical research 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 clinical research Investigators Meetings to ensure relations with sites as well as active presentation as applicable clinical research Qualifications 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 clinical research trial endpoints Ability to support CTM with vendor related issues Sc.  clinical research or other degree in Life Sciences or equivalent eg. Nursing, medical or as identified in the respective region clinical research 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