SUMMARY:

Clinical Research Associate with a master’s degree in Chemistry, graduate in Regulatory Affairs and over 8 years of clinical research monitoring (14 years of pharmaceutical industry experience). Possess excellent site monitoring skills, thorough knowledge and understanding of the of drug development process, excellent cross functional communication skills and outstanding organization and effective time management skills to execute various studies following SOP’s, ICH guidelines, GCP as well as Confidential and local regulations. Proven ability to manage over 17 clinical trial sites and work under minimal supervision.

TECHNICAL SKILLS:

Software Application: Clinical Trial Management System, Electronic Data Capture, IWRS, e - Diaries, eTMF, Microsoft: office, Word, Excel and Power Point, OutlookPublication

PROFESSIONAL EXPERIENCE:

Confidential, Philadelphia, PA

Sr. Clinical Research Associate

Responsibilities:

• Monitor clinical sites ensuring that studies are executed following the study protocol, Confidential SOPs/WPs, applicable regulations and the principles of ICH-GCP.
• Independently and proactively coordinate all study required activities for site selection, initiation, monitoring and closeout.
• Involvement, when required, in areas of study management and staff . Contribute to the review of Confidential systems and procedures, as appropriate.
• Coaching and mentoring of competences for less experienced colleagues.
• Contribute to the culture of process improvement with a focus on streamlining processes, adding value to our business and meeting client needs.
• Recognize, exemplify and adhere to ICON’s values centering around a commitment to People, Clients and Performance.

Confidential, Philadelphia, PA

Sr. Clinical Research Associate

Responsibilities:

• Managed clinical sites according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulations, and internal and/or Sponsor SOPs.
• Maintained accurate & timely Sponsor/site communication and correspondence.
• Completed Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to company SOPs
• Generated quality trip reports within company specified timelines to summarize the monitoring activities while including significant findings, deviations, deficiencies and any recommended actions to be taken. Prepared follow-up letters to Investigators based on the findings.
• Ensured subjects were informed about all trial procedures and knowingly agreed to participate prior to their involvement in any trial related activities.
• Ensured the trial was conducted in compliance with the approved protocol, GCP and applicable regulatory requirements.
• Ensured the reported data was accurate, complete and verifiable from source documents.
• Ensured the safety of clinical trial subjects by being vigilant in reviewing data to ensure all SAE’s and AE’s are documented and reported in accordance with company SOPs, GCP and ICH Guidelines.
• Monitored data quality while on site and remotely through EDC systems.
• Performed ongoing reviews of Investigator Files to ensure all regulatory and GCP documentation is complete and accurate in compliance with company SOPs, GCP and ICH Guidelines.
• Completed, confirmation and follow up letters to all visit types according to SOPs.
• Participated in departmental and project team meetings.
• Assisted with, mentoring, and development of newly hired CRAs, e.g. co-monitoring.

Confidential, West Point, PA

Clinical Research Associate

Responsibilities:

• Managed clinical trials sites, coordinating all activities and ensuring that trials are conducted on schedule and data was accurately generated, documented and reported in compliance with the protocol, GCP, applicable regulatory requirements and company SOPs.
• Ensured assigned sites were always “audit ready.”
• Performed Observational Visit as well as Sign Off Visit for newly hired Clinical Research Associates
• Reviewed Trip Reports of entry for mid-level Clinical Research Associate
• Completed Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs
• Ensured the protection of the rights, safety and wellbeing of clinical trial subjects and the credibility of data collected by clinical sites.
• Verified that proper inform consent procedures were followed and documented as per GCP prior to subjects participating in any study related procedures.
• Ensured site compliance with study drug protocol, Confidential regulations, ICH guidelines, GCP and HIPAA
• For any protocol amendments, ensured that IRB approval was obtained and all necessary documentation was filed.
• Monitored data quality while on site and remotely through EDC systems.
• Performed ongoing reviews of Investigator’s Site File to assure the site binder was complete and up to date with the essential documents in compliance with company SOPs, GCP and ICH Guidelines.
• Completed confirmation letter to, and follow up letters from all visit types according to SOPs.
• Generated quality trip reports within company specified timelines.
• Closely collaborated with other members within Clinical Trial Management (CTM) and with various vendor team members to ensure synergy and coordinated response to study issues.
• Maintained weekly contact with clinical trial sites.

Confidential, West Point, PA

Study Research Associate

Responsibilities:

• Conducted monitoring visits to confirm protocol compliance, assessed qualifications of study personnel, ensured “Good Clinical Practice”, and conducted close-out visits.
• Responsible for maintaining regulatory documents from investigative sites participating in Clinical trials
• Performed Site audits on behalf of Confidential to ensure the CRO and sites were in compliance with the company’s SOP, Protocol and Confidential regulations.
• Performed periodic Trial Master File audits on behalf of Confidential to ensure the research was being conducted in compliance with federal and local laws.
• Performed investigative site file reconciliation: requested any new and updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines and company SOPs.
• Liaised with CRO study Team members and provided weekly update, via presentation to Clinical Directors
• Maintained lists of investigators in various databases
• Coordinated the posting of Regulatory Binder and Study Manual materials
• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.

Confidential, West Point, PA

GMP Quality Auditor

Responsibilities:

• Coordinated cGMP activities for development of drug products in Pharm R&D
• Audited procedures, data, and laboratory to ensure compliance with cGMP and company SOP’s.
• Released drug products for clinical supplies through the review and approval of manufacturing documentation.
• Performed manufacturing facility qualification inspections.
• Conducted cGMP audits to include mock Confidential audits to ensure readiness for commercial manufacture, conformance to application (NDA/ANDA) and data integrity.
• Provided cGMP to personnel.

Confidential, West Point, PA

Scientist, Chemistry

Responsibilities:

• Represented functional area in project and analytical working group meetings in collaboration with Engineers, World Wide Quality Assurance, Early Development Analytical, Packaging, Stability and Contract Research Organizations.
• Provided analytical in-process support for Investigational drug product development and scale-up.
• Performed intermediate and drug product analytical method development to identify potential issues impacting the quality of intermediates and drug product and authored the analytical methods.
• Validated analytical methods and managed method transfer activities to CROs by authoring the method transfer protocol as well as the validation report, setting the Investigational drug product release specifications and performing all the required method transfer testing.
• Played a primary role in IND/NDA filings by completing required method validations, stability testing and drafting the related documentation in support of regulatory filings.
• Performed peer reviews for notebooks, memos, reports and various regulatory filling documentations in support of IND/NDA fillings.
• Performed GMP testing and documentation for monitoring intermediate and drug product stability to determine storage conditions and shelf life.
• Performed GMP release testing and documentation for Investigational product and placebo formulations to be used for Clinical Trials supplies for Phase I- III studies. Shipped the Investigational product to Supplier for packaging prior to shipping to CRO.
• Authored the analytical section of the bio-batch protocols for the manufacturing of drug products for clinical use.
• Authored several SOPs detailing instructions to achieve uniformity of performing the specific analytical functions with the focus on repeated applications or unchanged processes within the functional area.
• Successfully performed as a Member of the safety team tasked with implementing ways to reduce safety violations and incidents to make the work place safe for employees.

Confidential, West Point, PA

Staff Chemist

Responsibilities:

• Represented functional area in protocol meetings and pre-study meeting in collaboration with Toxicology, Pathology, Gene Toxicology, Study directors, compound leaders, Program Coordinators, World Wide Quality Assurance, Analytical Sciences, Analytical Chemistry, Process Research, and Bioprocess Research (BPS) in conducting safety assessment studies.
• Led central pharmacy sub team discussions to drive key decisions and worked with BPS to resolve any drug substance preparation issues that arose. Kept management informed.
• Responsible for authoring the test article portion of all regulatory documents in support of regulatory filings.
• Responsible for the preparation and distribution of the test and control article dosage forms used on conducting pre-clinical projects while adhering to GLP’s and maintaining strict accountability of the test and control articles to insure quality and integrity during testing in pre-clinical research trials.
• Responsible for receipt, storage and inventory of the test and control articles. Meet tight timelines for compound repack, shipments and delivery worldwide ensuring customer satisfaction and allowing for programs to proceed without delays. Fostered relationships and collaborations through global communications
• Utilized diverse knowledge and background in chemistry by assisting coworkers in trouble shooting and problem solving technical issues that arose in the course of the study.

Confidential, Rahway, NJ

Staff Chemist

Responsibilities:

• Worked on more than 10 early and late stage projects including Confidential approved Confidential .
• Developed short analytical methods that reduced sample analysis time Assumed responsibility for coordinating major parts of the project including analytical support for process development, pilot plant campaign activities, scale-up, transfer to Quality Operations sites and all related regulatory studies.
• Provided critical data and set specifications for drug substance, raw materials and intermediates in support of pharmaceutical research development.
• Responsible for coordinating and supporting all outsourcing operations activities for intermediates and GMP starting materials including setting specs for vendors, answering all analytical questions vendors may have, drafting memos, preparing outsourcing packages and performing release testing for pre-shipment samples.
• Played a primary role on IND/NDA filings by completing required method validations, stability testing memos and drafting the related documentation in support of regulatory filings.
• Communicated project updates and challenges through department meetings, presentations and written reports.
• Developed and validated analytical methods to identify potentials issues impacting the quality of intermediates and API.
• Performed GMP release testing and documentation for raw materials and Active Pharmaceutical Ingredient (API) for safety, formulation and Clinical Phase I- III studies. Performed GMP testing and documentation for monitoring drug substance stability and evaluated safety assessment material.