We match sponsors, CROs, and site networks with high performing investigators. Get insight into investigator qualifications and experience, then use our resources to aid with clinical investigator and site selection.

Advancing regenerative and gene therapies for the benefit of human and animal health.

P4 Management Partners is focused on advancing the practice of more preventive, predictive, personalized, and participatory health care for humans and animals.

Develop monitoring plan for clinical trial. Ensure team compliance with monitoring plan.Develop Specifications and participate in User Acceptance Testing for Data Analytic Tools and Electronic Data Capture.Responsible for development of training materials and training team of CRA and CTAs on Protocol and Risk Based Monitoring methods and tools. Ensure team is adequately trained on therapeutic area, study and are prepared to evaluate site staff during Site Qualification Visit and train staff during Site Initiation Visit.Perform national protocol training to Principal Investigators and Site Staff.Liaise with site staff or investigators conducting the trial to ensure monitors are meeting expectations.Oversee trial site, ensuring each site has appropriate trial materials to conduct study.Oversee site activation process.Develop and monitor metrics to evaluate monitor and site performance. Escalate concerns or risks appropriately.Track patient enrollment and recommend solutions to increase enrollment of qualified subjects as necessary.Oversee data queries, ensure appropriate time to closure and provide support as necessary.Review and approve visit reports.Generate protocol Informed Consent Form Template.Review Site Informed Consent Forms and site related materials.Plan and participate in Investigator Meetings.Oversee issues across sites and studies. Lead on route cause analysis and execution of Corrective and Preventative Action Plan (CAPA) as necessary.Oversee generation, response and closure of queries and time to closure of queries- by site and by monitor. Identify any trends and potential corresponding issues. Participate in Risk Analysis of studies with Sponsor and Key Opinion Leaders.Perform weekly and monthly review of study timelines, site start up, site activation, recruitment, subject study progress, monitoring progress, data trends, issue identification and closure.

•Analyze and evaluate clinical data including Case Report Forms (CRF) and source documents, to ensure subject safety, investigator compliance, and site adherence with the study drug protocol, overall clinical objectives, and FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA. •Lead CRA in successful independent audit.•Assist the development, execution and implementation of a Corrective and Preventative Action Plan (CAPA) at a study site.•Assist in site identification and feasibility. Conduct site qualification, initiation, trial master file assembly and maintenance, study staff training, routine monitoring, and close-out visits.•Verify data collected are in agreement with source, initiate data queries and confirm resolution in timely manner.•Verify drug accountability logs and storage requirements; and assure that investigational product (IP) is supplied to only those subjects eligible to receive it per protocol.•Manage trip reports, letters, query resolutions and expenses in accordance to project specific timelines.•Identify, document and resolve deviations or deficiencies relating to a site’s study data and/or conduct. Track study progress and ensure data integrity.•Assure site compliance with SAE reporting processes as well as reconciled SAE/AE listings. Ensure subject safety and adverse event reporting to sponsor and IRB/IEC.•Create clinical project documents and study material according to the protocol; including, but not limited to, protocol training material, IP administration and storage, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports and Case Report Form (CRF) completion guidelines.•Maintain frequent contact with and work effectively with investigators, and site coordinators.•Maintain close communication with clinical sites to assure adherence to protocol, GCP and regulatory guidelines, maximize study enrollment and resolve problems.

• Collected and reviewed regulatory documents from clinical sites; and communicated with sites regarding trial start-up, conduct, and close-out activities.• Audited Central Files in preparation for client review of clinical site files and maintain regulatory tracker for central files.• Assisted Clinical Research Associates on site with drug accountability, retrieval of patient Case Report Forms, and review of the site regulatory binder.• Assisted in the development and maintenance of patient visit and status tracker for 10 clinical sites.• Fielded phone inquiries from 10 clinical sites and provided backup support to Clinical Research Associates when they were traveling to sites.• Assisted in the receipt, review and recording of SAEs internally.• Assisted the clinical team in the review of protocols, informed consents, case report forms, monitoring tools, clinical study reports and other study-related materials.• Maintained working knowledge of protocols; served as contact for clinical sites; fielded questions for all clinical team members.

•Responsible for analyzing regulations and maintaining protocol and results records in accordance to federal and state U.S. law and international standards; providing an integral part of the clinical trial recruitment strategy.•Subject Matter Expert for Protocol Registration on CT.gov. Sole manager of all clinical trial registrations, point of contact for all registration inquiries, analyze changes in regulations and maintain compliance of all current records, maintain all updates and analyze each update for completeness according to policy. Review source documentation (i.e. Protocol Synopses), advise team members on best practice for posting.•Developed new efficient method for protocol registration data entry, create training material, develop training method, and facilitate training for regulatory and clinical members on new process.•Subject Matter Expert for Protocol Registration on International Websites, including Australia, Netherlands, UK, and India. Analyze international regulations, stay up to date on changing international regulations, developed method for maintaining compliance while posting across multi-national registries. Developed and maintain system for tracking and communicating differences among each international registry’s data elements per each clinical trialinternational clinical trial transparency requirements.•Analyze regulations to develop global corporate standard operation procedures and work instructions concerning clinical trial transparency work process.•Communicate with trade associations, regulatory global product leaders, regulatory affairs, and clinical research teams to ensure all protocol records are accurate and in compliance with federal and international laws and regulations.• Clinical Trial Transparency System Selection Core Team Member. Worked with Clinical Trial Transparency team to develop and document internal requirements for purchasing a sufficient system for Genzyme’s Clinical Trial Transparency needs.

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for the Protocol Initiative; an internal initiative to improve the process for scientific document development, worked directly with the Director of Medical Writing.Organized and developed a global Genzyme template and guidance document incorporating ICH, US and EU requirements for preparing clinical trial protocol synopses, protocols and protocol amendments according to the FDA and European Clinical Trial Directive and Clinical Investigation of Medical Devices for Human Subjects guidelines.Responsible for identifying and incorporating all required and suggested material and language for each protocol element and building each element into a working Microsoft Word template. Proficient in all Microsoft Office applications.

an Artist Development & Management Company with brands in magazine publishing, alternative marketing, touring, concert production, music education, and software design.Producer, writer, interviewer and host for Destination: Rock Show an online webisode series documenting experiences behind the scenes in the music industry. Director of the Sidehatch Underground All Ages Family Art and Concert Events.Developed relationships with, and recruited sponsors, maximized funding and grants.Manager of financial affairs.Manager of marketing plans for each event; worked with graphic artists to develop fliers and posters; organized street teams to distribute marketing materials and bring awareness to each community an event was held.Booked venues, bands and artists throughout the east coast.Organized employees, volunteers, sponsors, artists, bands and activities at each event. Developed the brand for Wicked Good Scene Magazine, helped create the brand image and launch strategy for Wicked Good Scene Magazine.

a biotechnology company that develops and manufactures sustained release injectables. Alkermes specializes in pioneering alternative drug delivery mechanisms. Physical and chemical characterization supervisor.Wrote technical reports and protocols.Conducted testing on geometric and aerodynamic particle size distributions.Quantification and analysis of pulmonary and injectable drug products using RP-HPLC, GP-HPLC, particle size and GC methods.Coordinated studies and managed the daily activities of two research associates.Safety Manager for Analytical Development Laboratories, OSHA certified, CPR certified.