Clinical Research Coordinator II
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; maintaining and updating data generated by the study, all IRB submissions such as application, amendments, annual reviews and adverse events, and communicating with national and international research collaborators. Assists with clinical research studies as per study guidelines and protocols. Screen for eligibility, recruit and evaluate potential study patients. Per protocol instruction, conducts telephone interviews or schedules patients for in-person study visits and screening. May be required to perform clinical tests such as questionnaires, cognitive assessments, etc. if certified and as needed. Will work with colleagues in research labs to set up lab testing, shipping, etc. Responsible for collecting data and maintaining the patient information database for several studies. It may be required to input data. Maintains study subject records as a part of the record-keeping function. Prepares data for analysis and data entry. Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up. Prepare materials to advertise studies. 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.
Requirements
- Bachelor's Degree Science required
- Related post-bachelor's degree research experience 1-2 years required
- Excellent interpersonal skills are required to work with the study participants, PIs, research collaborators, colleagues and supervisors.
- 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.
- Able to multi-task on several project simultaneously, and shift focus multiple times per day
- Able to work under deadline pressure
- 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.
- Ability to work with vulnerable subjects (pregnant women with neurologic illness).
- Basic knowledge of human anatomy, physiology, pharmacology
Responsibilities
- Assists with clinical research studies as per study guidelines and protocols.
- Screen for eligibility, recruit and evaluate potential study patients.
- Per protocol instruction, conducts telephone interviews or schedules patients for in-person study visits and screening.
- May be required to perform clinical tests such as questionnaires, cognitive assessments, etc. if certified and as needed.
- Will work with colleagues in research labs to set up lab testing, shipping, etc.
- Responsible for collecting data and maintaining the patient information database for several studies.
- It may be required to input data.
- Maintains study subject records as a part of the record-keeping function.
- Prepares data for analysis and data entry.
- Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up.
- Prepare materials to advertise studies.
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
