Clinical Research Associate
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Reports to the Business Manager and is accountable to Research Project Leads (RPLS) (Neuroscience Research Unit). Under the direction of RPLs and project clinicians, the Research Associate supports provides technical, regulatory, and administrative support on high priority portfolio projects moving to, or in, the clinic.
* Support the technical, regulatoratory, and administrative needs of high-priority portfolio projects within Pfizer Standard Operating Procedures.
* Manage regulatory submission documentation according to regional regulatory submission requirements and Pfizer standards.
* Navigate Pfizer compliance systems and registries (e.g., Clinical Trial Registries, GDMS, pTMF, etc).
* Assist RPLS and Clinicians in managing the workflows for QC, scientific and final review of GDMS submission components, as well as management of document workflow in the Trial Master File (e.g. CDPs, protocols, PQCCs, GIPs, IBs, INDs).
* Provide technical expertise in reviewing, managing, performing a Quality Control assessment and/or drafting pertinent clinical trial documents under the direction of the project Clinician (e.g., Data Safety Monitoring Board charters, Informed Consent Forms, expanding core protocol elements into full protocols, confidential disclosure agreement templates, consultant agreement requests, etc).
* Ensure compliance by assisting Clinical interactions with regulatory agencies, Institutional Review Boards, and all pertinent Pfizer processes.
* Responsible for updating Clinical Trial Registries with pertinent information and documents under the direction of the project Clinician.
* Collaborate as required and directed with internal partner lines in Development (e.g., DevOps, Business Development, Contracts and Outsourcing, Finance, Legal, etc) to ensure optimal project execution.
* Provide administrative support for the planning and management of key internal and external meetings (e.g., Investigators' Meetings, Advisory Board meetings, External Data Monitoring Committee meetings, etc.).
* Partner with Development Directors to provide general project coordination, including scheduling meeting, producing agendas, and document management.
* Bachelors Degree (B.A. or B.S.) at a minimum..
* Two years of pertinent academic or industry-based clinical trial experience.
* Strong working knowledge and understanding of the drug development process, applicable regulatory guidances and corporate clinical trial execution standards (e.g., Good Clinical Practices); with particular emphasis on Phase 1 and 2 clinical trials.
* Knowledge and success in monitoring multiple projects simultaneously.
* Internal working knowledge of Pfizer's processes a plus.
TECHNICAL SKILLS REQUIREMENTS
* Computer skills- Word, PowerPoint and basic Excel; SharePoint experience a plus.
* Experience with preparation of high quality business system documentation and procedures.
PHYSICAL POSITION REQUIREMENTS
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is required to sit; climb or balance, stoop, kneel, crouch, or crawl. The employee may occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include peripheral vision and depth perception.
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must be authorized to work for Pfizer in the U.S. at the time of the commencement of employment. Foreign national applicants who will need employer immigration sponsorship to obtain or continue work authorization must disclose that fact as part of the application process. Pfizer may consider in its sole discretion sponsoring a foreign national applicant for work authorization and/or permanent residence (green card) depending on its business needs.
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