Clinical Trials Proj Spec I B

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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 H

Compensation Range:

$26.90 - $37.66

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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