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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Pearl River, New York
job type: Contract
salary: $30.00 - 36.69 per hour
work hours: 9 to 5
The Clinical Data Reviewer (CDR) is a specialized role within Vaccine Clinical Research that performs clinical data review, typically ahead of significant project milestones (interim analysis, study closeout, submission etc.). The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis such as reviewing data for submission, highlighting errors, raising queries etc from a clinical perspective.
- The CDR may be responsible for the clinical data review of one or more studies with the ability to move easily from project to project as necessary.
- The studies supported by the CDR are often, but not exclusively, comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets.
- Ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications.
- Responsible for review of participant level data across a study in adherence with the Data Review Plan and for coordinating with Lead Clinical Scientist for study level review as delegated.
- Interpret data and identify issues of simple/moderate complexity in the data.
- Review tasks include both point-to-point data checks (e.g., verifying the presence of a temperature that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies the patient's data).
- Review study protocol deviations and ensure they are correctly and consistently reported and captured in the database.
- Collaborate with VRD laboratory personnel to ensure sample collection process is implemented correctly in the study.
- Create and use data review best practices and associated data review tools to identify trends and any safety signals.
- Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
- Attends Clinical Meetings and Study Meetings, as necessary.
- Relevant Clinical background or Data Management experience.
- BS Degree- Minimum with 3-5 years' experience
- Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
- Prior InForm EDC experience preferred.
- Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date).
- Proficient in accessing internal data systems such as CITRIX platform (JReview) to obtain data review listings.
- Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis.
- Strong attention to detail.
- Ability to work independently and as part of team.
- Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)
skills: MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.