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1. FSE JOB DESCRIPTION
NOVO NORDISK SCRA
JOB TITLE: Clinical Research Associate
REPORTS TO: ICON DOCS Operations Manager
SECTION 1: 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.
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
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
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 products
Ability and willingness to adjust quickly to new situations in a continuously developing environment
High degree of trustworthiness
Act as an ambassador for NN values
Flexibility is very important due to the large number of minor and major tasks coming from different customers
SECTION 4: EDUCATION REQUIREMENTS
( List requirements in bullet format )
Skills, experience and education:
Minimum of 2 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
B.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
Responsible and accountable
Excellent communication and negotiation skills
High focus on delivery and quality
Adequate English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports
Proven decision making and problem solving capabilities
Ability to manage multiple priorities
Team oriented personality with high degree of flexibility
Critical thinking in site management
Leadership skills awareness – ability to lead and support junior colleagues