Research Coordinator (Non-R.N.), II
Job Summary
Coordinate day-to-day research activities in adherence to Responsible Conduct for Research (RCR), study protocols, and applicable regulations. Implement processes and organize efforts within study team to achieve objectives, coordinate activities, and support research study initiation and close out. Conduct pre-study site visits, monitoring or other site visits at locations or sites participating in the study. Create and maintain tools and documentation to track study procedures, protocols and metrics, providing updates to management. Maintain source documents and report adverse events. Recruit, screen, enroll, and obtain consent from study participants. Collect and maintain study participant data and other forms of study data. Work directly with study participants and serve as project liaison to other departments, outside organizations, and government agencies. Works under the direction of the Primary Investigator (PI) or Project Director (PD). Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.
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Responsibilities
1. Reviews assigned research protocols in detail, including study objectives, study design, inclusion/exclusion criteria, visit schedule, and other details as needed.
2. Prepares, submits, and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
3. Coordinates participant study visits and related facility, drug/device, and equipment availability.
4. Obtains informed consent and addresses participants' concerns in conjunction with the PI.
5. Completes, audits, and revises relevant case report forms (CRFs) and enters data into electronic data capture (EDC) systems.
6. Accesses Electronic Medical Record (EMR) to obtain medical/surgical history, lab values, and other relevant data.
7. Carefully maintains source documents and subject logs to help ensure subject safety.
Minimum Qualifications
EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).
Research Coordinator (Non-R.N.), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
Preferences
- Bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
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