Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP, procedures and protocol requirements to ensure data quality and study subject protection.
Responsible for managing the site to meet patient recruitment rate and target.
Delivers results that have direct impact on the successful completion of the clinical program.
Coordinates with PM and communicates to them progress and critical issues that may impair trial progress.
- 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 1+ years on site CRA experience to include different visit types, SEV, SIV, MV, COV.
- 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