Andrea Sharp Email & Phone Number

Acworth, Ga, Us

Research Triangle Park, Nc, Us

Served in the CRA-CTM hybrid role since June 2022.

Research Triangle Park, Nc, Us

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Rolling Meadows, Illinois, Us

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• May provide assistance to more less experienced clinical staff.

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• May provide assistance to more less experienced clinical staff.

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.• May provide assistance to more less experienced clinical staff.

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.•Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.•Assist with periodic review of study files for accuracy and completeness.•Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.•Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.•Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.•Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.•Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.•Perform assigned administrative tasks to support team members with clinical trial execution.

Managed pharmaceutical studies and enrolled patients from all over the state of Mississippi.•Assisted with physical exams, dispensed study drugs, screened patients for numerous studies and followed their behavior throughout hospital stays.•Performed various test such as: YMRS, MADRS AND PANSS.•Submitted IND reports, AE’s and SAE’s to the IRB in a timely manner.•Attended numerous Investigator’s Meetings.•Consented subjects•Demonstrated Good Clinical Practice, SOP’s and resolved queries.•Conducted marketing strategies in order to obtain new studies•Involved in study acquisition set up with various Sponsors.•Research activities include lecturing on various diseases, EKG’s, blood draws/lab processes, vitals, drug administration and accountability, scheduling, communicating with the IRB, accounting for investigational products, CRF and study completion, managing data and monitoring staff. Key Contributions & Accomplishments:•Retention & Client Satisfaction – Delivered data with high-level accuracy through keen attention to detail. Enrolled the highest number of subjects and maintained the highest level of retention in 3 studies. •Professional Development – Strengthen my ability to maintain organization in stressful situations.

Bookkeeping, receiving and billing insurance companies, greeting clients, travel arrangements and tasks for general office procedures. •Duties for daily accounting procedures include post accounts receivable to the proper accounts, accept payments, prepare bank deposits, payroll, balance business accounts, checkbook reconciliation, quarterly tax payments, information recorded include patients name, amount of claim, date of claim, date of payment and amount of payment, responsible for small petty cash disbursement funds.

Facilitated the development of children’s reading and communication

Taught 25 students the fundamentals for dancing•Motivated students to excel in life

Provide legal secretarial support for two attorneys and one paralegal. Duties include word processing, filing, composing cover letters, preparation of timesheets and some client contact and other secretarial related responsibilities.

Master Of Science (M.S.), Management

Bachelor Of Arts, Communications