TITLE: Regional Clinical Research Associate - MI/MN - Princeton, NJ

Job Description
Responsible for performing study site management activities regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Develop and maintain collaborative working relationships with clinical investigative sites.

RELATIONSHIPS:

Reports to the Senior Regional Manager/Regional Manager, Field Trial Operations. Receives direction on individual clinical studies by the Site Management Lead, Project Manager and Clinician responsible for that project. Other internal relationships include other functional groups within CTO. External relationships are with clinical investigative sites.

ESSENTIAL FUNCTIONS:

CLINICAL TRIAL COORDINATION AND MAINTENANCE
· Serves as the primary contact for clinical investigative sites on multi-therapeutic trials.
· Contributes to the site and investigator selection process for their area of responsibility by making appropriate recommendations and pre-investigational site visits to evaluate site facilities and staff to ensure protocol and Federal Regulations will be adhered to.
· Performs and facilitates study start-up activities including site initiation and training, providing site level information for country recruitment plan, etc. and evaluate site recruitment activities. Ensure site understands protocol requirements, study conduct, and adherence to ICH-GCP guidelines, local regulatory requirements and NNI core and local SOPs.
· Accountable for ensuing that sites meet the performance expectations with regards to recruitment, randomization and retention (planned vs. actual targets).
· Conducts on-site visits and on-site/off-site monitoring activities to ensure clinical investigative sites are complying with study protocols, FDA regulations, company SOPs, ICH Guidelines and GCPs including confirming patient eligibility, protocol compliance, tracking patient enrollment, reviewing informed consent forms, maintaining project and visit timelines, ensuring accurate transcription of data from source documentation to CRF/EDC and addressing data inconsistencies and clarification with the site staff and relevant NNI functional groups.
· Adhere to all performance and productivity expectations with regard to site management activities.
· Maintains close contact with clinical trial site personnel and assists site with set-up, coordination and problem solving during the conduct of a clinical trial.
· Writes and submits timely and accurate monitoring reports, site contact reports and study correspondence/documentation (including documentation, approval and follow-up of protocol deviations) per FTO monitoring requirement.
· Performs site level drug accountability, reconciliation and destruction activities. Verify storage and shipment requirements are within study standards. Ensure timely completion of paperwork for shipment and storage deviations.
· Ensures proper return and destruction of all investigational study drug, including return and disposition of study related supplies and equipment.
· Verify storage and shipment of biological samples and other protocol specific diagnostic requirements.
· Ensure regulatory files at the sites and in NNI archives are current and in compliance with GCPs and NNI SOPs. Verify timely submission of study documentation (including AEs/SAEs/Pregnancy Forms/safety reporting) according to local and NNI requirements.
· Responsible to ensure quality of the data recorded at the site as well as retrieved meet expectations. Accountable for meeting data retrieval timelines.
· Attends site audit and executes site audit action plan.
· Attends protocol training, teleconferences/web meetings, including timely follow-up of action items as requested.
· Efficiently document and communicate study site progress and issues/concerns to the project team in a timely manner. Address study site issues/concerns with Site Management Lead (SML) and the site by independently offering resolution strategies and documenting follow-up activities leading to satisfactory outcomes.
· Conduct study close-out activities and ensure investigator understands requirements for archiving clinical investigative files.
· May be asked to co-monitor at sites outside of assigned region in order to facilitate workload assistance.
· Build and maintain professional relationships with clinical investigative sites by communicating in an effective, consistent and timely manner.
· Ensure that mandatory entries for all business systems are in compliance with set department and trial goals (i.e. IMPACT, CATS, EDC, CSIIM, etc.).
· Utilize study tools and study/department websites as well as frequently updating required information on department websites.

TRAINING
· Attend relevant symposia, conferences and scientific meetings, as necessary.
· Ensure administered training plan is completed on time and passing scores obtained on all training modules.
· Ensure all quality training modules reviewed and signed-off within set timeframe.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

· Bachelors' degree (in science area) or registered nurse, (4 year degree).
· Requires a minimum of two years clinical trial experience within industry or healthcare setting; preferably in clinical monitoring.
· Clinical monitoring and experience in all phases of study life cycle, including start-up, interim and close-out required.
· Strong communication (written and verbal), negotiation, customer focus, self-motivation, analytical, organizational and time management skills required. Must have the ability to function independently with minimal supervision.
· Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, federal and local regulations, research process and scientific knowledge as relates to clinical trial conduct.
· Demonstrated computer skills (MS Office, Excel, PowerPoint). Previous experience with Electronic Data Capture (EDC) and a Clinical Trial Management System preferred.

OTHER:
· Works within Novo Nordisk's established policies and procedures and ensures alignment of their work to Novo Nordisk fundamentals.
· Embraces Novo Nordisk Values in spirit and actions.
· Willingness to travel 60-75% (~ 3-4 days each week) including overnight stays, may include international travel


Additional Information
POSITION CHANGE FORM: Old Territory - Kentucky, New Territory - MI/MN. Posting as a CRA Level 8 - Job Code T471F