Clinical Research Associate

Clinical Research Associate

Summary:

The Clinical Research Associate (CRA) in Biomeasures, Endpoints and Study Technologies plays a key role in assisting the operationalization and execution of internal clinical studies 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 studies. 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 is an 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 the Clinical Trial Manager has responsibility to assist and support for all study management aspects of assigned PfIRe Lab studies or may manage a unique part of studies (e.g. recruitment, scheduling, and ISF filing). This individual provides operational support to teams from study startup to study execution and involves face to face interactions with giving participants instructions for protocol related tasks during the study.

Responsibilities:

• Be a working member on a study
• Assist in 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
• Work with local SOPs pertinent to the specific site conduct of the PfIRe Lab
• Assist CTM with Pfizer compliance systems and registries (e.g. GDMS, pTMF, Clinical Trial Registries, monitoring visits, etc.)
• Assist in managing and updating all site-related documentation (protocols, consent documents, recruitment materials, training documentation, and notes-to-file)
• Provide support for Clinicians in the planning and management of key internal and external meetings
• Partner with Biomeasures, Endpoints, and Study Technologies (BEST) 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
• Conduct study procedures in the lab including instructing participants in study tasks
• Coordinate with the CRA to maintain an accurate calendar of study schedules to ensure adequate staffing of studies and keeping track of participants
• Develop eCRFs and working with vendor(s) on electronic data capture systems
• Subject compensation and communications during the study and post-study
• Interface with other functions including clinical, informatics, operations, and statistics
• Work with the technical lead on collecting clinical study data using mobile/sensor-based technologies of interest to the research team
• Contribute to writing manuals of study operations
• Work under general supervision and performs assignments using established procedures

Qualifications:

• Bachelor’s degree in science or related discipline
• A minimum of 3 years of relevant experience in clinical research
• Prior experience as a study coordinator or direct involvement in clinical trial conduct
• Prior phlebotomy experience preferred
• Working knowledge of GCP and ICH guidelines
• Good working knowledge of the application of digital and device technologies as well as information platforms is a plus
• Recruitment/people skills (recruitment, screening, informed consent procedures, study conduct, and follow-up)
• Excellent written and verbal communication and interpersonal skills
• Able to handle a moderate volume of highly complex tasks within a given timeline
• Strong organizational skills and ability to prioritize work
• Proficiency in MS Office: Word, Excel, PowerPoint, Project, etc.
• Team player mentality

Rate/Location:

• $28 - $31 per hour
• This is a fully onsite role in Cambridge, MA

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued, and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.

Salary : $28 - $31