Clinical Research Coordinator I - Neurosurgery
About The Position
Working under the supervision of the Administrative Director of the CNCT and the Principal Investigator and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; viewing/attending surgeries to collect specimens or data; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study, all IRB submissions such as application, amendments, annual reviews and adverse events. Assists with clinical research studies as per study guidelines and protocols. Recruit and evaluate potential study patients. Per protocol instruction, conducts telephone interviews or schedules patients for study visits and screening. May be required to perform clinical tests such as questionnaires, phlebotomy, EKGs, etc. if certified and as needed. Will work in phlebotomy lab to set up lab testing, shipping, etc. Will be asked to attend research-related surgeries to assist in specimen or data collection. Responsible for collecting data and maintaining the patient information database for the study. It may be required to input data. Maintains patient records as a part of the record-keeping function. Prepares data for analysis and data entry. Interact with patients/subjects regarding the study, including patient education, procedural instruction, and follow-up. Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff. Will serve as a liaison between patient and physician. First point of contact for study communication. Advocate for patients to ensure a good experience while in your trial and assure compliance. Communicates with sponsor companies, CRAs, central labs, and testing facilities, both external and internal. Responsible for scheduling all research meetings with monitors or sponsors. Creates, distributes, and files all study documents per protocol and updates them as needed. Responsible for various study information or packets, i.e., schedules, directions, and reimbursements to study participants. Responsible for staff study training. Prepares and submits all IRB documents: applications, amendments, annual reviews, and serious adverse events. Oversees study budgets and patient reimbursements. Monitors and sets up any needed equipment. Maintains inventory and orders supplies when necessary. Maintains all study regulatory documents. All research administrative tasks. Performs other duties as assigned Complies with all policies and standards.
Requirements
- Bachelor's Degree Related Field of Study required
- Some relevant research project work 0-1 year preferred
- Excellent interpersonal skills are required to work with the study participants.
- Good oral and written communication skills.
- Knowledge of clinical research protocols.
- Knowledge of GCP and ICH guidelines.
- Knowledge of computer programs, databases, etc.
- Able to work independently.
- Ability to problem solve quickly and accurately.
- Excellent organizational skills and ability to prioritize and delegate a variety of tasks.
- Careful attention to detail.
- Ability to demonstrate professionalism and respect for subjects' rights and individual needs.
Responsibilities
- Assists with clinical research studies as per study guidelines and protocols.
- Recruit and evaluate potential study patients.
- Per protocol instruction, conducts telephone interviews or schedules patients for study visits and screening.
- May be required to perform clinical tests such as questionnaires, phlebotomy, EKGs, etc. if certified and as needed.
- Will work in phlebotomy lab to set up lab testing, shipping, etc.
- Will be asked to attend research-related surgeries to assist in specimen or data collection.
- Responsible for collecting data and maintaining the patient information database for the study.
- It may be required to input data.
- Maintains patient records as a part of the record-keeping function.
- Prepares data for analysis and data entry.
- Interact with patients/subjects regarding the study, including patient education, procedural instruction, and follow-up.
- Answers any phone calls and inquiries regarding study protocol.
- Refers participants when appropriate to supervisor or clinical staff.
- Will serve as a liaison between patient and physician.
- First point of contact for study communication.
- Advocate for patients to ensure a good experience while in your trial and assure compliance.
- Communicates with sponsor companies, CRAs, central labs, and testing facilities, both external and internal.
- Responsible for scheduling all research meetings with monitors or sponsors.
- Creates, distributes, and files all study documents per protocol and updates them as needed.
- Responsible for various study information or packets, i.e., schedules, directions, and reimbursements to study participants.
- Responsible for staff study training.
- Prepares and submits all IRB documents: applications, amendments, annual reviews, and serious adverse events.
- Oversees study budgets and patient reimbursements.
- Monitors and sets up any needed equipment.
- Maintains inventory and orders supplies when necessary.
- Maintains all study regulatory documents.
- All research administrative tasks.
- Performs other duties as assigned
- Complies with all policies and standards.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
