*Overview*We are seeking a highly motivated Regulatory and Financial Specialist to join our team. This role offers an exciting opportunity to perform a variety of clinical study activities to include regulatory document preparation and maintenance, budget negotiation, invoicing, and revenue management, assist the Clinical Research Director/Manager and Principle Investigator in the conduct and support of site research studies*Duties** *Document and Submission Management:* Prepare, submit and manage all regulatory documents* *Protocol Management*: Oversee the initial setup, implementation, and ongoing management of study protocols and associated processes* *Data and Records Maintenance*: Maintain accurate and up-to-date research databases and study records, and ensure compliance with record-keeping requirements.* *Budgeting and Financial Analysis:*1 . Develop budgets for clinical trials based on study protocols and agreements2. Monitor and manage project finances, including analyzing budget-to-actual variances3. Track all financial activity from study activation through closure* *Invoicing and Revenue Management:*1. Generate and submit invoices to sponsors for services rendered2. Track payments and apply them to project accounts3. Manage accounts receivable (AR) and accounts Payable (AP) related to study costs4. Perform financial reconciliation to identify and correct discrepancies5. Train research staff on financial processes and best practices6. Communicate with research sites on financial matters, including payment status and invoicing7. Set up and maintain clinical trial project profiles within the clinical trial* *Support PI, monitor, and other staff as needed**Requirements:** Previous experience preferred but not required* Detail oriented* Strong task management, prioritization, and follow-up skills are needed to manage multiple responsibilities in a fast paced environment.* Proficient with Excel, Word and Adobe PDF* Able to work in a team setting* Ability to adapt to changes in regulations, project, and office needs..Job Type: Part-timePay: $14.00 - $17.00 per hourExpected hours: 16 – 24 per weekWork Location: In person
Job Title
Regulatory and Financial Specialist (Research)