In addition to the duties noted for Project Specialist II:- Supports assigned PM with initiating requests to Finance Department to generate customer invoices for project labor and expenses. - Assists in the development of Informed Consent Form using project specific knowledge and performs in-house Case Report Form review. - May lead and manage other assigned Project Specialists.- Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PM. Assesses and communicates KPIs for associated job tasks to PM with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PM. - Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. - May lead internal team meetings and portions of external team meetings as directed by assigned PM. - Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans. Prepares for and attends Investigator Meetings, Kick-Off Meetings, Quick Start Camps, and Quality Finish Camps. May serve as PS representative during external systems/process audits.- May train new employees assigned to project. May be assigned as a mentor to new project specialists.- May serve as primary customer contact when PM is out of the office. Seeks input from Project Director for customer support.

- Supports Project Manager (PM) to ensure contracted services and expectations of a clinical study are carried out by assigned project team in accordance with executed contract and Customer’s expectations - Assures compliance with local regulations, FDA Code of Federal Regulations, ICH-GCPs, and Company and Sponsor SOPs - Utilizes designated clinical trial management system to track and process clinical trial information, (e.g., regulatory documents, enrollment, SAE/ AEs, protocol deviations, supplies, IRB re-approvals, data queries) in order to provide analysis of information to PM- Tracks and analyzes project details and maintains internal systems for assigned projects within a therapeutic area - Updates Project Leadership and CRAs of sites and study status – prepares and presents analysis of project level details such as enrollment, regulatory document collection, and data collection/review- Acts as a liaison and facilitator between other operation departments within INCR for project related tasks and/or issues- May serve as project representative for internal and external TMF audits- Assists PM with projection and validation of financial backlog and project realization on assigned projects – includes review of regular financial reports and analysis of upcoming project events to verify financial forecasts- Processes and tracks vendor invoices, site invoices, and investigator grants payments on assigned projects- Oversees regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan

• Accountable for coordinating, overseeing and completing all administrative non-clinical/clinical functions on assigned trials - including data input, interaction with client and sites participating in studies, review of all study related essential documents – this included the start-up and close-out of assigned studies.• Managed the operation of a clinical administration team; coordinated the non-clinical/clinical aspects of multiple projects as well as being responsible for planning, coordinating, and overseeing the execution of the non-clinical/clinical aspects of research projects while adhering to established timelines and budgets set forth in the Master Contract. Supervised multiple clinical administration personnel, including the allocation of personnel hours as well as all HR related responsibilities which included mid-year and annual reviews, and the coordination of clinical research management responsibilities.• Facilitated all regulatory and administrative functions for assigned trials and ensured communication between various functional groups• Responsible for entering study updates into computer database, mass mailings and other non-clinical work for assigned studies including billing

In charge of buying media time and creative for all advertisements, ensured all in-house promotional materials were current (including brochures, calendars, banners, posters and table tents), managed special promotions with media partners and booked all entertainment

Wrote and produced radio commercials for local and regional advertisers, assigned production of commercials to on-air staff, and assisted in station promotions Worked an air shift as the co-host of an entertainment talk show on WMFD-AM and handled promotions for children’s station WAAH-AM

Oversaw a team that marketed the New Hanover County franchise of Domino’s Pizza (7 stores), managed promotions inside the stores and partnered in special events within the community as a representative of the company

Compiled commercial logs for on-air use, entered time-buy contracts, assisted with monthly billing and reception duties

Wrote and produced television commercials for local and regional advertisers, assigned production of commercials to production staff, assisted in station promotions and public service

Assisted in production of live television shows and commercials, (camera, audio, character generator, switcher), directed live local shows (including news and features) and commercials, wrote and produced television commercials for local and regional advertisers