Regulatory Research Coordinator (Part-time)

Cambridge Scientific is seeking a Regulatory Research Coordinator (Part-time) to work on-site with a leading research facility in Frederick, MD!

Excellent compensation available!

Individuals must be flexible to work hours during the day!

Duties: 
 Must be able to facilitate clinical research activities conducted by the Medical Division Special Immunizations program by assisting with Development, Implementation and evaluation of clinical research protocols, informed consents and case report forms to assure that research activity is conducted with regulatory compliance. Must be experienced in writing and submitting Standard Operating Procedures (SOP), Study Specific Procedures (SSP). Must be able to manage regulatory files and subject records. Will be responsible for reviewing all of the SAE reports submitted to sponsor Will be responsible for the completion of case report forms, data collection and protocol activity reports for Principal Investigators. Must be able to develop and revise SSPs and SOPs. Will be responsible for preparation of monitoring visits and audits; remediation of monitoring reports and Regulatory Affairs audit reports; protocol/CRF modification; CRF completion.

Requirements:Minimum of a BS degree in a scientific discipline Candidate MUST have 3 years of GCP regulatory/quality assurance experience A favorable NACLAC is required.  The contractor employee shall have interim clearance prior to reporting for the first day of work. Must be a United States Citizen. Special Immunizations may be required.  A confidentiality agreement must be signed.