Reports to: Chief Implementation/Operations Officer
Directly Supervises: Regulatory Specialists and Assistants, Contract & Budget Specialists and Assistants
Expectation for all employees: To support the organization’s passionate cause, vision, and FUNdamentals by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, accountability, and ownership.
Position Purpose: The Regulatory and Budget Manager will manage the Regulatory department by facilitating professional service in the clinical trials industry by processing regulatory documents efficiently; ensuring compliance with all FDA regulations in research documentation; communicating professionally with IRBs, CROs, and Sponsors; maintaining trial tracking documents and software. The Regulatory and Budget Manager is responsible for managing the Contract and Budget department by preparing, maintaining, and negotiating budgets related to clinical trial activities as well as reviewing clinical trial contracts for routine changes and negotiate Clinical Trial Agreement (CTAs) with sponsors. The Regulatory and Budget Manager will work in conjunction with other research sites and principle investigators.
Essential Responsibilities for Regulatory Department:
Ensures regulatory compliance and related quality control; ensures completeness and consistency of data inputted by staff for submission to Sponsor, CRO and IRB in multiple clinical trials
Serves as a subject matter expert on regulatory compliance; advises management and staff on regulatory compliance at all stages of clinical research
Determines whether regulatory requirements have been met and advises on actions to be taken in order to satisfy requirements when needed
Gathers, enters and/or updates data to maintain company records and databases; establishes and maintains electronic files and records for sites
Submits regulatory documents and other documents to Sponsor, CRO and IRB, as necessary, on behalf of the Affiliate sites
Assists in maintaining current regulatory documents during the entire clinical trial process
Processes and files new or revised documents electronically into SharePoint
Communicates all regulatory needs (updated CVs, IATA and GCP certificates, licenses and local lab documentation) to Regulatory Assistant
Prepares documents for regulatory binders and sends documents to Affiliate Sites for filing
Oversees staff’s maintenance of Regulatory documents (CVs, Licensure, Lab documentation, etc.) ensuring they are maintained and up-to-date according to regulatory requirements
Other duties and responsibilities as assigned
Essential Responsibilities for Contract and Budget Department:
Prepares, maintains, and negotiates budgets and prices?to be charged by the company for clinical trial?activities?
Reviews clinical trial contracts for routine changes and?negotiates?Clinical Trial?Agreements with Sponsors?
Evaluates all legal and budgetary issues that may not be covered in the draft Clinical Trial Agreement (CTA) or budget?
Coordinates the budget process by providing data, information, and expertise to Leadership for the use in decision making and budget?formulation?
Collaborates with Management to develop strategic plans and financial?forecasts?
Ensures that budget adjustments are made in accordance with legal and programmatic?requirements?
Reviews contractual documents on a highly time-sensitive basis and assist in the coordination of the signature?process?
Requests clinical budget and contact documents from sponsors and CROs?
Reviews clinical trial protocols?&?develops?internal budgets for presentation to Principal?Investigators?
Examines budget estimates for completeness, accuracy, and conformance with trial?protocol?
Reviews operating expense and revenue budgets to analyze trends affecting budget?needs?
Maintains clinical budget and contract checklist in appropriate?database?
Identify and analyze methods, policies, or programs that will lower costs or increase?revenue?
Reviews consent form for event of injury language as well as examine cost section language against the contract and budget to ensure?congruency?
Consistently maintain general knowledge of protocols and prepare amendments of budget and/or contracts as required by sponsors or as requested by principal?investigators?
Organizes the processing of study feasibility questionnaires and prepare budgets as?necessary?
Other duties and responsibilities as?assigned??
Approve PTO and timecards
Conduct regular performance reviews with employees
Conduct site-specific meetings
Train employees and model continuous improvement
Other supervisory responsibilities as assigned
At least 1 year of management experience in healthcare environment required. At least 1 year experience working within Regulatory.
Telecommuting is allowed.
About IACT Health
At IACT Health, we are a diverse team of specialists with a passion for excellence and a “Whatever it takes” attitude. We strive to maintain an atmosphere where respect and fun are valued just as much as hard work and dedication. Every member of the IACT Health team shares a passionate cause to Revolutionize Research and Change Lives. We focus on what the industry needs to see most: improved patient diversity, faster enrollment, more efficient processes, and superb data excellence. We can change this great industry, and we can help you find a career that changes your life!