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Clinical Research Coordinator Jobs
Company | ProSciento, Inc. |
Address | Chula Vista, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Research |
Expires | 2023-07-15 |
Posted at | 11 months ago |
- Assists with closed study files for archiving in long-term storage.
- Assists with review of regulatory binders for completeness and accuracy, as needed.
- Responsible for completion of logs (informed consent documents (ICDs), training, screen failure, etc.).
- Resolves study source document discrepancies including supervising and reviewing completion of documentation of discrepancies by Data Entry Associate or clinical operations staff.
- Assists with the review of relevant documents for accuracy.
- Reviews protocol for accuracy, logistics, and for training purposes.
- Assists with training or managing oversight of training compliance of specific protocol related items for the following departments: screening, recruiting, pharmaceutical services, project management, and clinical operations.
- Performs rounds in the clinic to check on subjects and review subject source for completion and protocol compliance.
- Communicates with study subjects regarding their study status and enrolment into the study.
- Participates in study source review and approval process.
- Ensures subject study binders are prepared for study visits.
- Schedules subject appointments, performs subject reminder calls, and instructs subjects regarding any medication washout per protocol.
- Responsible for managing study tracking tools, including study information files.
- Assists with training of new hire Clinical Research Coordinators.
- Assists with data entry, as needed.
- Participates in, and contributes to, study teleconferences and/or meetings, as requested.
- Supports staff in day-to-day clinical or administrative activities and procedures.
- Schedules and organizes monitor and sponsor on-site visits, as needed, including setting up pharmacy, lab, and Principal Investigator (PI) meetings with the Clinical Research Associate.
- Under direction of the PI, creates Notes to File for clarification around subject related matters.
- Supports staff in monitoring and recording subject response to treatment, questioning subjects on adverse events/serious adverse events during study and completing study specific subject information on serious adverse event form.
- Keeps the Clinical Trial Management System (CTMS) updated with pertinent information.
- Administers IRB approved informed consent forms to subjects following Good Clinical Practice Guidelines (GCP), as needed.
- Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities.
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets firsthand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
- Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus
- Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.
- Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn’t upset when things are up in the air; doesn’t have to finish things before moving on; can comfortably handle risk and uncertainty.
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