Company: Novella Clinical Resourcing
Closing Date: 07 Jan 17
Salary (£): 30,000 - 40,000
A 6 month contract opportunity to assistswith delivery of Safety and Regulatory services according to ICH-GCP guidelines, regulatory requirements and Novella SOPs and/or project specific procedures. Primary responsibilities include review, preparation and submission of regulatory safety reports (including expedited and periodic) to all applicable Regulatory Authorities, Ethics Committees, Institutional Review Boards (IRBs) and Investigators within defined timelines.
Novella Clinical is a global full service eCRO, committed to providing an outstanding service to our clients as well as our employees. We focus on providing excellent training and career development opportunities, encouraging growth from within our talented work force.This is a full time, contract position for 6 months, which is office based in Stevenage, Herts.
.ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Assists with and prepares safety reports for submission to Sponsors, Regulatory Authorities, Ethics Committees, IRBs and Investigators as applicable.
· Liaise with relevant internal departments to ensure timely submission of expedited and periodic reports to applicable Regulatory Authorities, Ethics Committees, IRBs and Investigators.
· Responsible for updating and maintaining Regulatory Submission tracker for assigned projects in collaboration with other internal departments such as Clinical and ISSC.
· Assists with SAE reconciliation as needed.
· Attends internal and client project team meetings and provides relevant team updates as required.
· Assists with vendor compliance for third party organizations that perform regulatory safety reporting on behalf of Novella Clinical Ltd/Sponsor.
· Assists with performing project related study close-out and archival tasks.
· May assist management in writing processes and developing documents related to Regulatory Safety reporting, including study-specific processes.
· Assists with developing and maintaining tracking reports related to progress of studies, communicating regularly with Safety Reporting Specialist and team on status of activities.
· Assists in the collection and maintenance of Safety Submission Regulatory Intelligence for the Novella Clinical Regulatory Safety
· Provides general administrative support to projects as requested (e.g., taking minutes, copying, filing, faxing, scheduling).
· May mentor and/or train new Regulatory staff.
· Performs other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
· Good written and verbal communication skills.
· Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Regulatory department activities.
· Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
· Ability to work independently, follow instructions/guidelines and demonstrate initiative with oversight.
· Basic knowledge of medical terminology.
· Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
· Strong time management skills.
· Demonstrates professionalism and presents a positive image of the company.
· Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
· Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
· Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
· Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
· Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
· Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
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