Clinical Research Associate
6 months ago
SECTION 1:
- 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 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.
SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES:
( List statements in bullet format )
- 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
SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS:
( List requirements in bullet format )
Communication:
- Organizational understanding is required to identify and prioritize stakeholder requirements
- Responsible for planning, coordination and communication
- Has major influence on the reputation and the results of the department, Region and company through motivational interaction with the site staff. Internal support is provided by being service-minded, meeting deadlines and by contributing to the continuous improvement of the
- Quality of the outcome from the area in order to constantly optimize clinical development at NN.
- Always bear in mind that customer satisfaction is the ultimate departmental and individual goal.
- Efficiency, quality and job satisfaction should always be safeguarded to the same extent.
- Actively contribute to adequate and timely information of all concerned within and outside the department. Professional and social relations should continuously be established and maintained, and each individual should actively contribute to developing a positive team spirit
Innovation and change:
- Design of working tools. Training and advice at investigator sites. Issues management and escalation of non-compliance.
- Independence, innovation and initiative should always be demonstrated when analyzing, prioritizing, planning and performing tasks either assigned by management or initiated by one self. Perform in compliance with NN Policies and NN Way. In order to fully exploit the resources within the project group, Clinical Operations department and within the Region, initiative to improve working procedures, quality and service is important
- Has substantial influence on department, project and hence NN results since each clinical trial is a unique contribution to the successful marketing of NN products. The recruitment of suitable patients according to agreed targets for time and quality is the basis for getting all contributions finished in time and for reaching a quality level being acceptable for approval or sales of NN
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