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Clinical Research Assoc (S)

Company: University of Rochester
Location: Rochester
Posted on: May 26, 2023

Job Description:

Under the direction of the Director of Dermatology Clinical Trials Unit (CTU), and with latitude to exercise independent judgment, the Clinical Research Associate will direct the planning, implementation and coordination of clinical research in the department of dermatology.
The responsibility of the Clinical Research Associate is to implement, design and coordinate all aspects of clinical research (from multi-center, international/national trials to single center investigator-initiated trials), including samples management and data analysis.
Under general direction and with latitude for independent judgment:

  • (20%) Works collaboratively with other CTU and department staff to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, perform basic clinical skills such as obtaining vital signs, ECG testing, phlebotomy, and other protocol specific activities (e.g. skin barrier assessment, skin microbiome samples collection). Participate in the ongoing informed consent process, ensuring that human subjects understand what is expected during the course of participating in the specific clinical trial. Records data form source documentation into case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness'. Ensures compliance with applicable regulatory requirements and IRB standards. Ensures integrity of all study data collected. Ensures protocol activities are administered consistently across study sites.

  • Keeps up-to-date with current federal regulations (i.e., FDA) for conducting clinical studies according to GCP's. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.

  • (20%) Responsible for all aspects of translational human subject research startup including: collaborating with investigators and coordinators on protocol development, protocol review, regulatory document preparation, consent form preparation, and submission to Institutional Review Board. Interact with Research Subjects Review Board to ensure all requirements, documentation and startup requirements are met for existing and new protocols. Develops, reviews and approves study-specific procedures manuals.

  • (25%) Develop database management tools for monitoring, analyzing and reporting on study participants. Utilize sponsor-provided software packages as necessary. Perform chart reviews for retrospective projects, working closely with clinicians to advance the field of dermatology. Collect, record, graph, and analyze data from clinical research study (e.g. clinical trials and chart review). Results must be organized and summarized in suitable form for presentation at research meetings.

  • (15%) Keep updated with current literature relative to specific area of dermatology clinical and translational research. Work closely with CTU director and PIs to develop manuscript, analyze data and present at national and International meetings.

  • (10%) Biospecimen handling and maintain an inventory of incoming samples collected as part of investigator initiated or sponsor trials. Process human samples (e.g. blood, skin biopsy or stratum corneum extract) for storage and/or shipping as per protocol. Will have to maintain an inventory of incoming and stored samples. Keeping inventory updated on sample tracking software used for this purpose.

  • (5%) Meets regularly with the CTU Director to ensure study progress, staffing, new study reviews, and research operations within the Department. Meets with the study investigators, sponsors, administrative staff, ambulatory clinical staff, and represents the Clinical Trials group at various meetings.

  • (5%) Maintains a working knowledge of area of expertise by attending pertinent meetings, seminars, webinars (OHSP, RSRB, SCORE, FDA, NIH, etc.) and reviews research literature.

    Bachelor's degree in appropriate discipline and 3-5 years of experience in basic and translational research as; or an equivalent combination of education and experience.

    • A Bachelor's degree in a science major such as Biology, Biotechnology, Microbiology, or Biochemistry (B.S. preferred) with undergraduate research experience. Lab courses should have provided a background in basic molecular biology techniques and data analysis.

    • Experience in clinical trial setting

    • Proficiency in PowerPoint, Excel, and Word, with a good understanding of statistics and experience with stat program (e.g. GraphPad Prism).

    • Experience with EPIC and RedCap.

    • Must have good communication skills for readily conveying scientific results and interacting with members of the scientific community.

    • Experience in scientific writing, including manuscript and abstract/poster, and data analysis.

      NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.
      The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
      How To Apply
      All applicants must apply online.
      EOE Minorities/Females/Protected Veterans/Disabled
      Location: School of Medicine & Dentistry

      Full/Part Time: Full-Time

      Opening: Full Time 40 hours Grade 053 Dermatology M&D

      Schedule: 8 AM-5 PM

Keywords: University of Rochester, Rochester , Clinical Research Assoc (S), Healthcare , Rochester, New York

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