Sr Clinical Project Coordinator

United BioSource Corporation. - USA - Brief Description: The Clinical Project Coordinator supports and works closely with management/project leaders, investigational sites, and Health Care Professionals (HCPs) to provide in-home visits for subjects enrolled in clinical trials. This role involves extensive communication and interaction with internal and external customers to ensure the clinical trial in-home activities within the contract and protocol are satisfied and performed in compliance with project specifications and applicable SOPs and in adherence to FDA regulations, HIPAA, and ICH/GCP guidelines. Activities involved in the provision of clinical trial in-home nursing services may include, but are not limited to, adherence to project plans, timely procurement of qualified HCPs, coordination of HCP training, visit schedules, and visit supplies, essential document management including data entry and quality assurance, and continuous support for internal and external customers. Assists management with other projects and initiatives as needed. Requirements: BA/BS degree with a preference for candidates with a medical or research backgrounds Ability to work in a fast-paced environment and support multiple projects concurrently Strong organizational skills and time management skills; ability to manage a variety of tasks and prioritize, track, follow up and meet deadlines associated with departmental and/or specific projects Attention to detail Strong analytical and problem solving skills; maintains composure under pressure Excellent written communication skills Excellent oral communication skills Strong computer/technical proficiency (Word, Excel, PowerPoint) Service oriented, flexible Able to work collaboratively and positively with management, teammates, and all other customers to achieve common goals Works independently with moderate supervision Demonstrates interest and willingness to learn job duties and positive adopter of change Supervisory Responsibilities: No Job Duties (included, but not limited to): Provides superior internal/external client/vendor support: Point of contact for investigational sites, vendors (including HCPs), and sponsors regarding logistics, documentation, and non-medical matters Communicates professionally and timely with internal customers (management, teammates, vendors) and external customers (investigational sites, clinical research organizations, and other study personnel) to achieve satisfactory query resolution, and enhance processes and service delivery Facilitates questions, provides guidance, and develops and follows through with solutions for routine project-related issues and problems; escalates issues appropriately as needed Escalates potential misconduct, fraud, or noncompliance to management HCP Procurement and Training Sources and facilitates contracting of home health agencies and/or HCPs, adhering to contractual obligations and budgetary constraints Coordinates all HCP training Provides HCPs with adequate training materials, study supplies, and equipment Coordinates visit schedules with sites, courier services, etc., as applicable Document Management and Quality Control Follows departmental processes for ongoing timely collection, quality review, data entry and storage/maintenance of essential documents to include: Group mailboxes and voice messaging Shared folders Internal data base (subject, HCP, contract facility information/documents) Study-specific management tools (e.g. tracking tools, meeting agendas/minutes/action items, change logs, etc.) Provides essential documentation timely to investigational sites Assists with and participates in audits as requested Miscellaneous administrative duties Other duties as assigned ABOUT UBC United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use. Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care. You can find out more by visiting... - Permanent - Full-time

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