Clinical Trials Proj Spec B

Position: Clinical Trials Proj Spec I B
Location: City of Rochester

Clinical Trials Proj Spec I B page is loaded## Clinical Trials Proj Spec I Blocations:
Saunders Research Building time type:
Full time posted on:
Posted Todayjob requisition :
R268071

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
** Job Location (Full Address):
** 265 Crittenden Blvd, Rochester, New York, United States of America, 14642
** Opening:
** Worker Subtype:

Regular Time Type:

Full time Scheduled Weekly

Hours:

40

Department:400981 Neuro-Ctr Health & Tech/CTCC

Work Shift:

UR - Day (United States of America)
Range:

UR URG 109 HCompensation Range:$26.90 - $37.66
* The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
*** Responsibilities:
** Supports all aspects of clinical research trials. Supports the clinical study team by assisting with collection, tracking, and review of study related regulatory documents from study sites and maintaining study files. Assists senior peers in supporting clinical trial sites. Helps prepare for various clinical study meetings involving both internal and external teams.
** ESSENTIAL FUNCTIONS
*** Requests, tracks receipt of, and reviews regulatory documents. Requests and tracks updated documents when necessary. Collaborates with study team to ensure that study file content and format are consistent with Good Clinical Practice, applicable regulations, and Standard Operating Procedures.
* Reviews site revisions to informed consent, ensures site changes are acceptable and advises sites when study documents are ready for Institutional Review Board (IRB) submission. Assists sites with questions related to IRB submissions as needed, under direction of senior peers.
* Under direction of senior peers, develops draft informed consent documents. Drafts revisions to existing informed consent documents to reflect changes in study protocol when necessary.
* Assists senior peers in preparing for meetings. Drafts minutes for project team meetings under the close supervision, direction and review of study team lead.
* Demonstrates ability to prepare IRB submissions.
* Oversees and coordinates human subject research activities for single and multiple sites. Develops, implements, and evaluates recruitment strategies, information, data systems, and study management systems. Participates in the planning, development, and implementation of a study design, budgets, protocols, consent forms, processes, and policies, including multiple therapeutic areas. Participates in the development, review, and approval of case report forms and study specific procedure manuals and documents.
* Other duties as assigned.
** MINIMUM EDUCATION & EXPERIENCE (Required)
*** Bachelor's degree
* 1 year or relevant experience
* Or equivalent combination of education and experience
** KNOWLEDGE,

SKILLS AND ABILITIES

(Preferred)
*** Clinical trials experience
* Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials
* Strong communication skills, interpersonal skills, attention to detail, and organization skills

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