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Consent Specialist
2 months ago
Groton, Massachusetts, United States
Pfizer
Full time
Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The Clinical Genetics & Biospecimens (CGB) team in Pfizer's Biomeasures, Endpoints, and Study Technologies Group seeks a meticulous Consent Specialist to support the operations of our biological specimen bank and the secondary use of clinical trial materials. You will assess and annotate allowed uses of clinical trial materials to enable adherence to ethical and other requirements. Your work will be a component of the stewardship and management of clinical trial materials including biospecimens.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Apply subject matter expertise to the review of clinical trial informed consent documents and summarize information regarding biospecimen, image, and data use and retention
Evaluate situations and identify those requiring escalation for resolution
Uphold adherence to Pfizer's policy on the use of human biological specimens, including
compliance with the terms of ethical review, subject consent, and other obligations
Propose and/or contribute to innovative process improvements related to consent review and codification, including incorporating artificial intelligence (AI) technologies to streamline activities
Assist with the delivery of orders for biospecimens and associated data
Qualifications
Must-Have
Bachelor's degree, preferably in the biological sciences
3+ years of experience in the areas of clinical trials, biomedical sciences, ethics, or other field relevant to the position
Working knowledge of human genetics and biomarker research
Ability to produce high-quality work products within established timelines while managing competing needs
Excellent reading comprehension skills
Strong written and verbal communication skills
Predisposition towards adherence to processes and procedures
Track record of building successful relationships with supervisors, peers,
customers, partners, and stakeholders
Aptitude for problem solving
Nice-to-Have
Previous employment in the pharmaceutical industry, particularly in relation to clinical trials
Knowledge of requirements, guidelines, and standards in relation to clinical trials, biospecimen collection in clinical trials, data privacy, and biospecimen use (such as Good Clinical Practices [GCP])
Practical experience in the review and interpretation of informed consent documents with a focus on the collection and use of biospecimens for exploratory research
History of effective collaboration with colleagues in other disciplines
Work Location Assignment: Flexible
The annual base salary for this position ranges from $74,900.00 to $124, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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