RN / Clinic Coordinator - Clinical Research Unit, New Haven -
Location: New Haven Connecticut
Description: Pfizer Inc is currently interviewing RN / Clinic Coordinator - Clinical Research Unit, New Haven - right now, this career will be placed in Connecticut. Further informations about this career opportunity kindly see the descriptions. Org Marketing Statement
Pfizer Inc: Working together for a healthier world
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to! our medicines and to provide better quality health care and h! ealth system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Job Focus
Assures clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines
Coordinates day to day execution of assigned protocols from recruitment through last subject, last visit
Leads a clinic team (e.g., nurses, techs, sample processers, phone screeners, clinic screeners) to ensure subject safety, accurate interpretation of medical tests and execution of research protocols (e.g., ICD development, recruitment plans, source document creation, specimen collection activities)
Responsibilities
Oversees the collection and documentation of electronic and/or written study data; responsible for data integrity and completeness
Oversees subject coordin! ation (activity sheets, bed space, follow up visits)
Supports the recruitment of subjects for research activities conducted at the CRU; schedules and tracks potential subjects; maintains electronic and hard copy records; follows-up referral appointments/treatments as directed
Supports informed consent activities as needed; creates, maintains and administers informational tools to assist volunteers with study comprehension and compliance
Develops/maintains/improves technical capabilities/competencies necessary for conduct of studies in the CRU (e.g., drug administration, clinical/physiological measurements, sample collection/processing, basic nursing care, emergency care)
Accountable for timely review and archiving of audit-ready volunteer data in accordance with SOPs and GCPs
Actively participates in ensuring overall coordination of protocols, including study scheduling, protocol planning, and managing CRU resources (study budget! s, supplies, equipment, and contract staff)
Participates in QC! of study set up in the electronic data capture system for protocols according to protocol requirements, CRU SOP’s, and standardized processes, as appropriate
Responds to and resolves queries specific to subject data collection
Leads the clinic study teams (nursing, techs, and contract staff) within the unit in executing the assigned protocol
Works with the regulatory lead on timelines and submissions for screening
Works with the CRU study team (e.g., PI, PM, Director of Operations) to develop and implement recruitment strategies
Partners with the PI to screen subjects for eligibility using protocol inclusion/exclusion criteria
Assists in study design as it relates to feasibility, implementation, and reporting of clinical trials
Reviews and provides input on protocols; interprets protocol detail and organizes study activities including the creation of study documents
Develops customized recruitment st! rategies/tools/documents to support subject recruitment (e.g., patient trials), as appropriate
Assists in the orientation of new CRU clinical colleagues and contractors, mentors and coaches other clinic personnel as needed
Collects and maintains volunteer demographic and medical information
Prospectively classifies potential study subjects in accordance with PIMS policies
Coordinates and documents participation of individual subjects in all clinical research activities
Creates and distributes study calendars for subject use
Interprets protocol activities for study subjects and ensures comprehension and compliance
Reviews/analyzes active charts (PIMS) to find appropriate subjects to enroll in current studies
Schedules prospective subjects for screening
Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
Ensures that all subject records are consiste! ntly maintained in a state of inspection readiness; performs ongoing qu! ality reviews of the data to achieve audit-readiness and to meet strict archiving timelines
Leads or supported ICD development, informed consent session and subject orientation sessions
Contributes to the development of screening tools
Collects screening or study-related biologic specimens and clinical measurements (i.e., ‘second floor’ activities), as appropriate, to maintain competency, assure quality, and adhere to protocol requirements
Coordinates menus, meals, vendor interaction and and any related study-specific training
Coordinates external labs (study set up, shipments, data management) and data management/CRF/RDC execution
Assures subject safety, including assessment of physiologic response to drug administration associated with administration of study medications by various routes (e.g., PO, IV, IM, SC, transdermal, pulmonary)
Monitors cardiac function/status and provides emergency interventions, a! s appropriate
Supports general staff training activities (e.g., telemetry, pulmonary function, EEG requirements, ACLS/BLS, ECG, vital sign)
Supervises the initiation and monitoring of all study activities for assigned protocols
Evaluates adverse events and intervenes as appropriate; maintains accuracy, accessibility, and confidentiality in subject records and reports
Demonstrates professional communication and behaviors which facilitate positive attitudes and trust by the subject population toward participation in clinical research
Available for various shifts (weekends/ evenings/ nights)
Qualifications
No relocation assistance available for this position, please only apply if you are able to relocate yourself.
Training & Education:
Bachelor’s degree in nursing or related discipline required
Health care practice experience/training (e.g., nursing, paramedic), with valid license, preferr! ed
ACLS and BLS certification
Understanding of local ! regulatory requirements (e.g., ICH, GCP)
Understanding of the regulatory inspection process
Understanding of the drug development process
Bilingual an asset
Prior Experience:
General medical-surgical nursing or related experience
Ability to execute a variety of clinical safety measurements/assessments (e.g., ECG, vital signs, phlebotomy)
Previous clinical research, industry, phase 1 and/or drug development experience preferred
Proven ability to function as an effective and professional team member in diverse workgroups to accomplish business objectives.
Working knowledge of computers, medical conditions, research techniques, and the application of clinical research
Excellent communication skills required (written, verbal, including telephone)
Prior marketing/recruitment experience an asset
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 have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obta! ining, maintaining and/or extending the temporary visa status and/or sp! onsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Pfizer Inc.
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This career starts available on: Tue, 03 Dec 2013 18:31:07 GMT
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