SUMMARY:

• Broad range of therapeutic experience
• Proficient in teh technical/scientific noledge required for comprehension and execution of clinical protocols
• Possession of teh requisite organizational and logistics skills to ensure effective management of multiple sites and protocols wifin timeframes and on budgets
• Superior written and verbal communication skills
• Ability to work in a matrix and fast - paced environment
• Demonstrated ability to train and mentor clinical research staff
• Ability to constructively interact directly wif Sponsor personnel
• Computer literacy, including proficiency in MS Office, IVRS, CTMS and use of EDC systems

PROFESSIONAL EXPERIENCE:

Clinical Research Associate II,

Confidential, Billerica, MA

Responsibilities:

• Support teh site identification process and suggest sites to be considered for selection
• Conduct pre-study site visits and recommend sites per teh site selection guidelines
• Provide assistance in teh collection, review and tracking of essential pre-study documents as required.
• Conduct site initiation visits for selected sites to train teh site personnel on teh protocol and proper study conduct.
• Conduct monitoring visit to review source documents and case report forms to ensure that essential documents are current and complete and filed in teh site’s regulatory binder.
• Ensure that all study drugs shipped to teh site are properly accounted for and that subject is dosed correctly per teh protocol and pharmacy guidelines.
• Identify deficiencies and/or discrepancies and provide additional and/or initiate corrective action as required
• Follow-up wif teh site to assist in resolution of significant problems or issues noted during site monitoring visits.
• Conduct site closeout visits, as required and ensure that all study drugs are properly reconciled, to include test article reconciliation and disposition, review of accuracy and completeness of study files, and retrieval of all outstanding documents.
• Prepare comprehensive and detailed reports documenting study status, site issues and monitoring activities wifin specified timeframes.
• Communicate wif study sites to ensure that all clinical aspects of teh trial are adhered to in accordance wif teh protocol and Sponsor directives as well as state and federal regulations, guidelines and/or policies; provide on-going instruction to research site personnel, as necessary, on proper conduct of teh trial.
• Ensure timely and proper completion of by assigned clinical sites.
• Follow-up on safety issues at teh site especially adverse events (AEs) and serious adverse events (SAEs) as necessary and reconcile SAEs wif teh clinical .
• Assist in teh resolution of queries.
• Manage time, expenses and visit frequency per study guidelines.

Clinical Research Associate,

Confidential, Cincinnati, OH

Responsibilities:

• Visited sites to assess teh qualification of potential investigative sites, initiated studies, instructed site personnel on teh proper conduct of studies, to review and ensure accuracy of collected and to terminate studies
• Monitored clinical trials to ensure sponsor and investigator obligations were met and compliant wif applicable local regulatory requirements and ICH guidelines
• Provided regular clinical status information to team members and project management
• Performed billable work in accordance wif company policies, procedures, and Standard Operating Procedures
• Worked closely wif other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff.
• Communicated common site trends to Lead CRA and other project team members
• Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency wif other documents, and compliance wif appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
• Performed source document verification, retrieved Case Report Forms (CRFs) and performed query resolution in a timely manner and performed drug accountability and safety at investigative sites
• Ensured Serious Adverse Event (SAE) reporting according to project specifications
• Responded to requests from investigative sites in a timely fashion
• Mentored junior level CRAs and serves as a resource for new employees
• Served as a resource for and interacted wif other functional areas to resolve site issues and facilitated project timelines
• Scheduled and reviewed project tasks, provided leadership in teh delivery of services to clients, ensured that staff fulfilled their responsibilities in accordance wif company policies, procedures, and SOPs, and ensured HR processes were properly implemented

Clinical Monitoring Associate,

Confidential., Cincinnati, OH

Responsibilities:

• Collaborated wif CRA on site issues/actions
• Created and distributed study documents (e.g. eSignature Agreement, Amendments, etc.)
• Updated all relevant tracking system on an ongoing basis
• Maintained site staff details
• Performed regular reviews of according to review/monitoring guidelines (CTMS, EDC, IVRS, ISIS)
• Conducted remote visits (initiation, monitoring, termination)
• Collected updated/amended regulatory documents in collaboration wif CRA and CTS as needed
• Reviewed recruitment plan and enrollment updates and addressed/resolved issues pending from teh previous visit
• Addressed protocol questions and checked on site staff assignment
• Assessed drug/study supply status and requested outstanding documents
• Followed-up on entry, query status and SAEs
• Maintained a working noledge and ensure compliance wif applicable ICH-GCP Guidelines, local regulatory requirements and specific procedure (e.g. Monitoring Plan)

Sales Manager,

Confidential

Responsibilities:

• Created and executed product awareness plans and program through adequate product noledge
• Maintained account relationship wif medical doctors to ensure account retention
• Provided on teh job to pharmaceutical sales rep
• Effectively managed five sales reps to ensure teh of department’s target.
• Achieved outstanding increase in sales revenue wifin 12 month period (200%)