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Clinical Coordinator, Sr. Associate

Pfizer


Location:
New Haven, CT
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

Shares responsibility for the overall operation, excellence, quality, integrity, compliance, and safety of the New Haven PCRU clinical trial coordination and clinical services operations, including planning, data acquisition, and sample collection activities.







Assures clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements and guidelines.







Leads efforts in day to day coordination and execution of assigned protocols from recruitment through last subject last visit (LSLV).







Accountable for clinical oversight, subject safety, and regulatory compliance during shift operations including weekends and off-shift hours.







**JOB RESPONSIBILITIES**







+ Manages overall clinical coordination of protocols, including study scheduling, protocol planning, and clinic resources.



+ Leads the clinic in maintaining subject schedules and tracks follow-up referral appointments.



+ Provides expert clinical input and quality control (QC) review of protocol-specific database configuration in Electronic Data Capture Management System (EDCMS).



+ Provides expert clinical input to develop and implement general and targeted subject and patient recruitment strategies.



+ Leads efforts in screening subjects for eligibility using protocol inclusion and exclusion criteria and liaises with Principal and Sub Investigators (PIs / Sub-Is) accordingly.



+ Provides expert clinical input in the development of study protocol design as it relates to feasibility, implementation, and reporting of clinical trials.



+ Leads efforts in comprehensive reviews and provides expert clinical input on draft study protocols and Informed Consent documents (ICDs).



+ Ensures that all subject records are consistently maintained in a state of inspection readiness.



+ Performs ongoing quality review of data to achieve audit-readiness and to meet archiving guidelines and timelines.



+ Provides technical expertise and assistance in managing biometric Subject Verification System (e.g. VCT).



+ Provides input and assists in the efforts and direction of Volunteer Advocacy Committee (VAC).



+ Leads and ensures real time data collection monitoring as well as 24-hour paradigm of quality data cache review.



+ Represents NHCRU clinic as SME (Subject Matter Expert) for various special projects, e.g. PIMS upgrades, SOP (Standard Operating Procedure) development, process mapping, and work flow instructions.



+ Provides visitors from within and outside of company tours of the clinic space and gives pointed specifics on clinic functionalities.



+ Upholds the tenets of Good Documentation Practice (GDP) and Good Clinical Practice (GCP).



+ Leads initiatives in implementation of Quality Framework Document and embeds quality controls and quality assurance in clinical work and process flows at all times.



+ Ascertains GDP compliance of all paper source documentation used in clinical studies and partners with Clinical Document Compliance Specialist (CDCS) accordingly.



+ Leads efforts in continuous and dynamic clinical staff development and study specific protocol training and liaises with Technical Training Manager (TTM) accordingly.



+ Provides study specific protocol expertise and input on project planning, timelines, execution, and implementation as well as acquisition of specialty equipment.



+ Collaborates with Brussels PCRU Clinical Coordinator counterparts to align and share clinical coordination best practices.







**QUALIFICATIONS / SKILLS**







+ Minimum of Bachelor of Science degree in Life Science, Biomedical Science, or equivalent prior related work experience required. Bachelor of Science in a health related field preferred and/or matriculation in a college degree program preferred.



+ Certification from nationally accredited industry organizations with knowledge of various regulatory requirements from FDA, ICH, and GCP preferred, e.g. Regulatory Affairs Certification (RAPS), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).



+ Minimum of 3 years work experience in clinical research trials, i.e. as a clinical research nurse, data collector, clinical research technician, study coordinator, or data manager preferred.



+ Exhibits quality with high degree of ethics and integrity performing clinical research activities in accordance to laws, regulatory standards, industry guidelines, and company policies and procedures.



+ Proficiency and expertise in Microsoft (MS) Office and the ability to learn different software programs.



+ Experience in Phase I Management Systems (PIMS) EDCMS platform preferred.



+ Proficiency and expertise in using Subject Verification System.



+ Current certification for Basic Life Support (BLS) required.



+ Certification for Advanced Cardiac Life Support (ACLS) highly desirable.



+ Technical expertise and proficiency in venipunctures, intravenous cannulation, and performing 12-lead electrocardiograms preferred.



+ Ability to recognize basic normal cardiac rhythm and broad identification of abnormal cardiac conduction.



+ Excellent command and fluency in English language (verbal and written).



+ Bilingual ability to speak, read, and write Spanish is highly desirable.



+ Experience in public speaking and delivery of scientific, medical, and nursing educational presentations.







**EEO & Employment Eligibility**



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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Additional Offer Details:**







+ Last Date to Apply for Job: November 13, 2017



+ This job is Pfizer Exempt US/PR Grade: 006







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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