Clinical Research Assoc (S)
Company: University of Rochester
Location: Rochester
Posted on: May 26, 2023
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Job Description:
GENERAL PURPOSE:
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.
SPECIFIC RESPONSIBILITIES:
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.
REQUIREMENTS:
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.
Preferred:
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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