Clinical Research Coordinator- Neuropharmacology

Responsibilities

• Screens potential study subjects for possible protocol entry using inclusion and exclusion criteria
• Explain specifics of research study, including requirements, medication, potential side effects, and medical care received or refers to investigator when appropriate
• Explain testing procedures associated with study, including psychometric tests, and diagnostic or interventional procedures or refers to investigator when appropriate
• Updates patients or subjects of current research study findings
• Updates patients on results of study findings when completed
• Interprets patient medical records, or refer to investigator where appropriate
• Reviews laboratory/diagnostic tests or refer to investigator where appropriate
• Identifies potential study candidates through review of physician appointment lists, patient medical records, and general advertisement
• Performs study procedures, including subject interview, vitals, ECGs, and psychometric testing, and other required protocol tasks as delegated by the investigator and documents performance in source document and case record form
• Updates database programs for study computers where appropriate, including patient randomization, correspondence, and hotline reports
• Collects and documents data for research project, via the following:
• Creates and maintains case report forms along with summary sheets for convenient data analysis
• Creates labeling system for data collection
• Communicates with sponsor study monitor to ensure proper data collection as well as to gain feedback on how study is proceeding
• Establishes familiarity with various medical departments for collection of data (MRI films, CT, radiographs, etc.)
• Arranges schedules and appointments, including study subject visits, study staff schedule, and location of study execution
• Implements system to dispense and return study medication within the FDA guidelines. Organizes and completes paperwork for volunteer fee schedule of payments, including where appropriate, W-4 forms, declaration of participation, and eligibility sheet
• Shipping and receiving and maintains inventory of study supply, including drug
• Stores study supplies, drugs, and biologic fluids in accordance with the protocol and maintains calibration and temperature requirements
• Assists with updating Standard Operating Procedures (SOPs) as required
• Archives study documents in accordance with contracts and SOPs
• Maintains a database of potential and former study volunteers, including information on health status, and address and phone number information
• May perform diagnostic testing, such as ECG, and may draw blood if trained or certified
• Maintains regulatory documents necessary for compliance with human subject regulation including but not limited to IRB communications and documentation
• Prepares Continuing Review documents to submit to IRB
• Processing patient samples
• Communicating/maintaining supply inventory when applicable
• Conducting/maintaining laboratory quality controls weekly to monthly dependent on scheduling and staffing

Preferred

• Bachelor's degree or equivalent training
• Prior clinical research experience
• CPR certification

Benefits

• Work-Life Balance (no overnight shifts)
• Medical, Dental & Vision Plans
• Life Insurance
• 401(k) Retirement Plan
• Critical Illness, Accident, & Legal Plans
• Wellness Program
• Learning & Development Opportunities
• Paid Time Off
• Paid Holidays
• Free Onsite Parking at All Locations
• Outpatient neurology practice providing neurodiagnostics and specialty neurologic care.
• Amherst, New York, USA
• http://dentinstitute.com
• Growth Stage
• Leadership Team
• Christine Czech-Mann
• Chief Operating Officer, Director of Infusion Operations, Managing Partner NeuroNet GPO
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Qualifications

• Strong interpersonal and communication skills
• Excellent organizational skills
• Problem-solving skills
• Computer skills
• Ability to manage multiple projects at different stages
• Laboratory skills particularly pipetting
• High level of communication of interaction with others is required via direct verbal and telephone dialog and in written form; nature of interactions is to give or receive information and knowledge, and to instruct
• Bachelor's degree or equivalent training
• Prior clinical research experience
• CPR certification

Required skills

• CITI Training, CPR Certification, IATA Certification, NIH Training, Phlebotomy Certification, Pipetting

Preferred skills

• Bachelor's degree or equivalent training, CPR certification, Prior clinical research experience

Experience

• Mid level