The Study Coordinator (Immunobiology) provides patient management, clinical, regulatory and administrative support for clinical research protocols. This position relies on experience and judgment to plan and accomplish goals, functioning and participating as a member of a Clinical Research Team.
- Recruit and schedule eligible participants for research studies via telephone, mailings, and face-to-face interactions. Maintains participation of study subjects by developing positive relationships, scheduling follow-up appointments, and encouraging continued involvement.
- Cr eate and implement recruitment strategies to identify eligible participants and inform potential participants about the research and eligibility criteria. Assess inclusion/exclusion criteria.
- Schedule and coordinate study visits and testing.
- Able to assent and consent study participants.
- Perform protocol specific tests and procedures.
- Assist with the collection of blood, urine, and tissue samples.
- Ensure that study visits are completed and documented per protocol.
- Process laboratory samples and deliver samples to local laboratories or mail to central laboratories. This includes processing, aliquotting, labeling, and shipping samples as needed.
- Assist with completing and maintaining study data collection forms, source documents, and case report forms.
- Maintain study regulatory documentation.
- Prepare for and attend audits/monitoring visits. Aid in resolution of queries.
- Prepare IRB applications, progress reports, and informed consent forms.
- Assist with reporting and managing adverse events.
- Assist with reporting and managing protocol deviations.
- Clean and restock exam rooms and labs. Assist nursing and laboratory staff.
- Order supplies and equipment for studies.
- Attend training and in-service sessions.
- May assist in grant and protocol writing as needed.
- Perform basic administrative tasks as needed (photocopying, faxing, etc.).
- B achelor’s degree in Biology/Chemistry or other related science, public health or related field (for RNs a BSN is required). Master’s degree preferred.
- Minimum 1 year experience in clinical research setting.
- Experience with computer data entry and word processing.
- Demonstrated good organizational and interpersonal skills.
- Experience with communicating with IRB and clinical trials regulatory requirements.
- Ability to consistently perform detailed work to ensure accuracy in collecting and recording data.
- Ability to speak on a one-to-one basis to engage and recruit patients, and to explain study protocols and processes.
- Ability to prioritize assignments to complete work in a timely manner.
- Ability to work independently to coordinate study visits and track and maintain study data on patients.
- Flexible work hours are necessary with occasional weekend coverage.
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