Clinical Research Associate, Digital Medicine & Translational Imaging, Early Clinical Development

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

The Clinical Research Associate(CRA) inDigital Medicine & Translational Imaging plays a key role in assisting the operationalization and execution of studies conducted using Digital Health Technologies including those that will be run at the Pfizer Innovation Research (PfIRe) Laboratory in Pfizer's Kendall Square facility (Cambridge, MA). This individual will work collectively with research, technical, and clinical leads as well as key stakeholders to operationalize and conduct Digital Medicine clinical trials. A successful candidate must be experienced in communicating effectively with both potential and enrolled research participants during conduct of a clinical trial including but not limited to: recruitment, screening, informed consent procedures, study conduct, and follow-up.

Digital Medicine isan industry-leading mobile/digital technology initiative striving to utilize digital continuous remote monitoring of patients' symptoms as novel endpoints for disease diagnosis, physical function measurements, and health state assessment. The PfIRe lab is a clinical research unit outfitted with state-of-the-art technology where studies may be conducted utilizing wearable sensors, environmental monitors, and other novel technologies.

The CRA, in close partnership with Clinicians, Clinical Project Managers, and Study Managers, has responsibility to assist and supportstudy management aspects of assigned PfIRe Lab and Digital Medicine clinical trials. This individual will provide operational support to teams from study startup to study execution. In the PfIRe Lab, the role involves face to face interactions with participants, ensuring protocol-related tasks are completed, study monitoring activities and maintenance of the investigational site file and other study-related documents. The CRA may also work with Contract Research Organizations and vendors to conduct Digital Medicine trials.

It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Be a working member on a study and clinical trial teams
  
• Assist working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice, regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes.
  
• Working with local SOPs pertinent to the specific site conduct of the PfIRe Lab.
  
• Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established SOPs under the general management of Study Manager and/or Clinical Trial Manager.
  
• Performs clinical study site management/monitoring activities in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), Pfizer standard operating procedures (SOPs), Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  
• Work with clinical operations, study teams, and Clinical Research Organizations (CROs) to support clinical study activities
  
• Assist in managing and updating site-related documentation (protocols, consent documents, recruitment materials, training documentation, and note-to-files).
  
• Provide support for Clinicians in the planning and management of key internal and external meetings.
  
• Partners with Digital Medicine and Translational Imaging colleagues on internal study execution. These responsibilities may include but may not be limited to activities including:
  
  ·Communication with interested and potential study participants both in the recruitment and screening phases of Digital Medicine trials.
  
  ·Conducting study procedures in the lab including instructing participants in study tasks.
  
  ·Coordinates with the Clinical Trial Manager to maintain an accurate calendar of study schedules to ensure adequate staffing of studies and keeping track of participants.
  
  ·Developing eCRFs and working with vendor(s) on electronic data capture systems.
  
  ·Subject compensation and communications post study.
  
  ·Interface with other functions including clinical, informatics, operations, and statistics.
  
  ·Work with technical leads on collecting clinical study data using mobile/sensor-based technologies of interest to the research team
  
  ·Contribute to writing manual of study operations
  
• Consistent with capability and experience, may support other study management activities such as vendor management, financial management, site payments and tracking, and TMF management of Digital Medicine studies
  

QUALIFICATIONS

Must-Have

• Bachelor's Degree
• 3+ years' experience as a study coordinator or direct involvement in clinical trial conduct
• Experience in clinical trial administration
• Demonstrated success/results in prior roles including matrix organization
• Demonstrated knowledge of quality and regulatory requirements across a range of different countries
• Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
• Knowledge of applications used in the clinical trials
• SOP compliance knowledge and expertise on all relevant SOPs
• Effective verbal and written communication skills, and must be fluent in English
• Proficiency in Microsoft SharePoint, SharePoint Designer etc

Nice-to-Have

• Master's degree
• Good working knowledge of application of digital and device technologies as well as information platforms is a plus
• High level of project management skills

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some limited number of weekend and time commitment outside of normal business hours may be necessary for certain study visits.

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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