Job Description
Responsibilities include but are not limited to being lead coordinator on a study, executing follow-up visits ongoing studies, query resolution and other study specific tasks.
The CRC I will perform daily tasks such as document review, data entry, test material preparation and data collection. This position may coordinate and execute projects assigned by the Clinic Manager while abiding by Good Clinical Practice (GCP) guidelines.
- Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information
- Responds to queries from Quality Assurance and Statistics departments
- Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs
- Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed to protocol, SOPs and GCPs
- Monitor Compliance of panelists
- Prepares and is accountable for all Test Material for managed studies
- Adheres to study budget
- Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents
- Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
- Coordinates scheduling subjects for visits
- Completes other duties or tasks assigned by Clinic Manager and / or Supervisor
Qualifications
EDUCATION AND EXPERIENCE
- Associate Degree or 2 years minimum of relevant work experience with a GED or High School Diploma.
- Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies
KNOWLEDGE / SKILLS / ABILITIES
- Language Skills
- Mathematical Skills
- Reasoning Skills / Abilities
- Computer Skills
- Ability to manage and coordinate multiple projects in a fast paced, highly professional environment.
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