•Oversees regulatory compliance of Investigator-initiated trials conducted at multi-center sites.•Write, and provides input on SOP's, WI's and internal Policies•Reviews PRI/Expedited reports prepared by MC Regulatory Associates prior to management review•Participates in interview of Regulatory applicants•Reviews and follows up on monitoring letters and audit reports to ensure action items/findings are addressed by MC Regulatory associates, and monitors trends•Assists in assessing workload capacity•Monitors activation of new sites and follows up with MC regulatory Associates to address items•Performs essential regulatory document collection to ensure that sponsor and investigator obligations are being met and are in compliance with regulatory requirements•Ensure accuracy and completeness of trial master file documents and perform quality review of files •Participates in monthly team calls and site initiation meetings and close-out visits•Provide updates to Principal Investigator, and study team to anticipate, identify and resolve issues•Provide regulatory guidance and quality assurance assessments for assigned research projects - domestic and international•Request and document Multicenter Sponsor Team training •Communicates with the Institutional Review Board (IRB) and research sponsor (Action Letter, Administrative Letter, NSI reports etc.)•Review protocols, consent forms, reports•Prepares part of IND Submissions and renewals to the FDA of multi-centers when sites utilize UNC IRB.•Participates in internal and external audits •Develop and maintain knowledge of institutional protocol submission procedures•Coordinate the preparation and submission of new studies to appropriate committees•Keep stakeholders informed of protocol approval and activation status•Prepare and submit amendments, continuing reviews, and deviations to appropriate committee•Participate in research audits and communicate status to the PI and research staff.

•Ensure accuracy and completeness of trial master file documents submitted during start-up and perform quality review of files •Liaise with team members to review areas that impact study to meet established processing deadlines •Participates in weekly team meetings and site initiation meetings and close-out visits•Provide updates to Principal Investigator, Project Manager, study team and clinical team to anticipate, identify and resolve issues•Identify and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations•Provide regulatory guidance and quality assurance assessments for assigned research projects - domestic and international•Prepare and submit regulatory documents and responses to study staff, sponsors, team members and monitors•Compile, edit, analyze, and report data/information for the purposes of communicating with the Institutional Review Board (IRB) and research sponsor (Action Letter, Administrative Letter, NSI reports etc.)•Review protocols, consent forms, reports, as appropriate for various clinical research projects to ensure compliance with regulations.•Create and edit SOPs, Work Instructions, and procedures for Regulatory Operations, as needed•Prepares part of Investigational New Drug Submissions and renewals to the FDA •Comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research•Prepares regulatory documents and participates in internal and external audits •Monitor paper and electronic regulatory files for monitor visits, giving assignments and instruction as needed•Understand and follow Good Clinical Procedures

• Answer multiple line switch board for facility• Prepare and retain records, files, and reports in accordance with facility, federal and state standards• Responsible for running and printing patient census• Responsible for resident trust withdrawals/deposits, collecting bill payments and balancing resident trust daily• Receive in coming/outgoing packages, create shipping labels • Fax confidential information, made copies of documents for the doctor and other staff personnel

• Daily monitoring and correcting employee missed time punches and compiling time reports for Department Heads• Ensure the processing of new hires, temporary workers, transfers, promotions andterminations is accurate and timely• Communicate actively with Operations, HR and Billing to review cross-departmental impacts and reconcile data sharing• Review and analyze current payroll, benefits and tax procedures in order to recommend and implement changes leading to best-practice operations• Ensure systems are set-up and updated to reflect our current employee base, including wages, benefits, sick and vacation time

•Process IMAC/Falcon Service Center Tickets and work queues for effective distribution and closure of tickets•Maintain and update surveys and floor plans with employee seating location and assist with employee relocations and move management requests•Perform download of information for the security card system and ID pictures•Liaison with other departments to collect data needed for service tickets completion•Track and order blackberries and office supplies for the entire Legal and Compliance Department•Coordinate processes for on-boarding new hires, transfers and/or terminated employees•Track and onboard FINRA, FED/FRB, OCC, OTC Examiners for exam purposes•Perform core administrative functions, i.e. update calendar, schedule client meetings, travel arrangements, prepare proposals contracts, office correspondence, manage multiple Excel spreadsheets, and PowerPoint (Author/Blue Book) presentations etc.•Maintain Equity Compliance training spreadsheet and upload data into Plateau training system•Update Equity Policy and Procedure Manuals•Compile monthly analysis of SEC Rule 605 data from Thompson Analytics (MSI) to compare broker-dealer best execution performance•Coordinate special projects, group conferences, client dinners, outings, networking events, luncheons etc.