Regulatory Coordinator

GENERAL DESCRIPTION

The primary responsibility of the Research Regulatory Specialist is to assist the study manager and research nurse/coordinators with the regulatory, pharmacy, and administrative aspects of clinical research.

QUALIFICATIONS

Knowledge of Microsoft Word, Excel, Publisher, and EDC (electronic data capture) software
Knowledge of GCP (Good Clinical Practices) and Research Protocols

CRITERIA FOR EVALUATION

A) Completeness and accuracy in performing assigned work
B) Organization in performing assigned work, including but not limited to timeliness in completing projects, neatness of work performed, and success in managing multiple tasks
C) Communication of all protocol-related question or problems to the research manager or coordinator
D) Professional conduct in the presence of patients, research staff, sponsors, monitors, etc.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING:

• Prepare all regulatory documentation for new study start-up (i.e., IRB submission, FDA Form

1572, Curriculum Vitae, Medical Licenses, Financial Disclosure Forms, etc.)

• Execute all job functions of the Unblinded Pharmacist (except for mixing) on all double-blind clinical studies (drug receipt, accountability, reconciliation, training of infusion nurses, etc.), as well as meet regularly with the IDM (Independent Drug Monitor)
• Enter patient data and resolve data queries in EDC for designated studies
• Routinely facilitate Site Selection visits, and attend Site Initiation visits
• Create dynamic advertising for recruitment of patients within the clinic, as well coordinate advertising efforts outside of Arthritis Northwest
• Prepare agendas for research meetings, as well as facilitate monthly research meetings
• Submit IND safety reports to sponsor as appropriate, as well as prepare them for signatures
• Prepare for signature and file all Sponsor and/or IRB documentation throughout the duration of the study
• Maintain quarterly financial records (i.e. payment received, patient stipends for study visits, payments to independent contractors, invoice sponsor as needed)
• Maintain Arthritis Northwest staff CVs/medical licenses, ANW laboratory license/accreditation and reference ranges
• Maintain Arthritis Northwest Equipment Maintenance calibrations
• Facilitate and conduct study close-out visit by the study sponsor
• Prepare documents for long term storage (i.e., archive study files, subject records, financial documentation, etc.)
• Record and monitor drug storage temperatures daily
• Maintain patient enrollment logs and confirm patient visits weekly
• Screen patient charts for study inclusion, as needed.
• Maintain inventory of laboratory supplies and department supplies on monthly basis
• Processing, packaging, and shipping patient lab samples as needed (IATA certified)
• Flexibility w/ hours and schedule
• Maintain filing of all ISF (investigator site files).
• Conducting patient visits, data entry, obtaining vitals (seeing this role does act as back-up research coordinator as needed)

Job Type: Full-time

Pay: From $20.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Spokane, WA 99204: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location