Clinical Research Associate

POSITION SUMMARY

Primary point of contact between site staff and NN. Acts as ambassador for the company and contributes to making NN the preferred partner.

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, NN 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 LTM and RTM and communicates to them progress and critical issues that may impair trial progress

JOB FUNCTIONS / RESPONSIBILITIES

• 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

Additional requirements :

• Knowledge of filing and archiving trial documentation in the Sponsor Trial Master File (STMF)
• Timeliness in deliverables through process planning and goal setting
• Knowledge of IW / VRS functions, incl. training of site staff
• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments · Monitor and communicate internally any site observations critical to business results
• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
• Support audits and inspections at sites and affiliate, as applicable
• Proficient use of Novo Nordisk systems (e.g. IMPACT, CATS, Investigator Portals)
• Ensure to list compliance / quality related tasks / responsibilities and specific, assigned acts of authority (QMS requirements) also include information on independence and decision-making authority