Conyers Lamm Email & Phone Number

Raleigh, Nc

*Oversee the contracted services and expectations of a clinical study are carried out by the assigned project team in accordance with the executed contract and the Customer’s expectations*Manage site participation for assigned projects with regards to site enrollment expectations, start-up document collection, contract negotiations, escalation discussions, and close-out activities*Develop and maintain project plans for the study in accordance with SOPs and WIs*Maintain effective communication with project team and keep the regional team informed of the study status *Oversee the regulatory document collection and submission process and ensure project documentation, including Trial Master File, are complete and audit ready

Raleigh-Durham, North Carolina Area

*Supports Global Project Manager to ensure the contracted services and expectations of a clinical study are carried out by the assigned project team in accordance with the executed contract and the Customer’s expectations*Manages investigator grant payments for assigned projects within North America*Tracks and analyzes project details and maintains internal systems for assigned projects within General Medicine business unit*Assures compliance with local regulations, Code of Federal Regulations/International Conference of Harmonization (ICH), Good Clinical Practices (GCP) guidelines, and Company and Sponsor Standard Operating Procedures (SOPs)*Keeps Project Specialists and Clinical Research Associates (CRAs) fully apprised of sites and study status

*Develop and implement four year operational budget for Seeds of Change Appalachia*Conduct complete operational budget reconciliation for Seeds of Change Appalachia initiative’s grant *Create and maintain in-kind contribution database for Seeds of Change Appalachia initiative *Process employee reimbursements, invoices, and payments for the Seeds of Change Appalachia initiative*Coordinate administrative activities for Heifer’s Seeds of Change Appalachia initiative, including, but not limited to organizing and tracking receipt of documents (Letter of Commitment, Conflict of Interest Statements, Activity Proposals, etc.) from coalition members, mass email communications to coalition and Steering Committee members, scheduling and coordinating fundraising activities, conducting meeting preparation activities, and assisting with grant proposal writing

*Coordinated and oversaw all administrative functions on assigned trials, to include, but not limited to, review and transmission of regulatory documents for proper and accurate content prior to submission to the central Institutional Review Board, FDA and/or the client; organized, managed and coordinated development of regulatory and financial packets, shared drives, computer system set-up; and, QC and QA of all project reports, tracking forms, mass mailings and faxes*Led administrative personnel, Clinical Research Associates, investigative sites, and client company personnel in the accurate completion of regulatory requirements and created and implemented processes to ensure regulatory compliance*Mentored and provided work direction for the research and project teams in the preparation and execution of all clinical administration functions*Developed, documented, and complied with study specific Process Manual for study team*Coordinated and provided project team training, assisted in the training of Project Assistants and assisted management in determining training needs of the administrative staff *Coordinated quarterly investigator file reviews; ensured files are audit ready; and contributed to company, client and federal regulatory requirements/audit responses*Accountable for investigator, Institutional Review Board, and all payments across studies

*Completed administrative functions on assigned trials, included, but not limited to, review and transmission of regulatory documents*Ensured consistency with filing, payments, and administrative processes across all studies*Attended site monitoring visits to conduct site file reviews and assist with source documentation review*Developed collaborative relationships with Clinical Research Associates, investigative sites and client company personnel*Coordinated various training activities on processes specific to administration.*Accountable for generating, resolving and clarifying queries and regulatory documents*Facilitated effective communication between client and company, vendors and project team in order to anticipate, identify and resolve issues for non-clinical/clinical aspects of assigned studies

*Provided day-to-day administrative support to the project team*Maintained central study files for assigned projects*Processed invoice requests and investigator payments*Corresponded regularly with investigators, team members, and sponsors on various project related issues*Tracked study data in the PPD database and offered organizational and administrative expertise*Assisted with the identification of potential investigators*Trained and mentored new Project Assistants in the departmentACTIVITIES

Chapel Hill, Nc

*Provided day-to-day administrative support*Scheduled dermatology appointments for surgical procedures and corresponded regularly with receptionists, doctors and interns regarding various patients and administrative concerns*Assisted with various correspondence to patients and other community doctors*Provided customer service to patients visiting the hospital*Maintained department administrative supplies and distributed mail/packages to the dermatology department

Mba, Sustainable Business Concentration

Activities and Societies: *Graduate Assistantship with the Economics Department

Bachelors, Psychology