• Reviews the study scope of work, budget, and protocol to be sure clinical team is aware of contractual obligations and parameters. Responsible for identification of critical data and process, protocol execution risks, and risk mitigations. Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.• Uses project oversight dashboards and clinical trial systems to oversee study KPIs, study and patient activities, study team conduct and ensure data is entered in a timely fashion, according to plan.• Works closely with project management to escalate any risks to management deliverables, and any activities and requests that are out of contracted scope. Accurately completes monthly forecasting using systems and tools, and attends monthly study health assessments with the executive project director.• Interacts with multiple clients including botech and cooperative groups, as well as other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management, and leadership as per departmental or study agreements. Provides solutions for obstacles to protocol execution and site management.• Demonstrates understanding of other functions’ roles in achieving study compliance and delivery according to protocol, SOPs, regulations. This includes data management, study start-up, regulatory and contracting. Supports inspection readiness for clinical trial management scope.• Oversees CRAs and Project Support assigned to the study and routinely assess study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develops and supports execution of corrective action plans at the site and study level, including responses to audits. Supports and completes activities to achieve data cut and lock deadlines.

• Writes medical patient education articles for over 25 independent chronic disease sites.• Translates complex medical articles into patient-accessible language (i.e.- 8th-grade reading level). • Communicates effectively to multiple chronic disease teams and patients, with a focus on clinical medicine and community-based wellness and education.• Handles multiple deadlines efficiently and successfully.

• Accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. • Leads and directs cross functional teams (Clinical Operations, Regulatory Affairs) and understands/manages client expectations. • Runs study from feasibility to close-out, including, budgeting, forecasting, resourcing, creating country-level regulatory documents, liaising with central IRB and any other clinical operations needs.• Supports and motivates clinical team and relevant staff, identifying opportunities for improvement, working to set priorities, and developing contingency and mitigation plans for risks. Liaises with Clinical Operations Managers to resolve clinical resource and performance issues. Identifies opportunities to improve training, execution, and quality control across the team. • Disseminates and distributes study level information to the local trial team. Plans, oversees, and conducts initial and ongoing training for the relevant study staff on clinical project specifics. Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution. • Leads study team meetings, identifying areas for improvement, ensuring effective communications and escalation plans are in place, and working with relevant staff to provide data as required for clinical operations performance metrics and project status metrics. Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team members.

• Provided quality review of the informed consent template.• Liaised with project team members regarding study site issues.• Documented site and sponsor contact and study interactions in a timely and professional manner. • Performed essential document collection, review, maintenance, and close-out activities, ensuring that sponsor and investigator obligations are being met and follow applicable local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements. • Performed study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete. Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. Utilizes the Clinical Trail Management System (CTMS) to ensure investigator recruitment activities are a accurately tracked.• CLIX Subject Matter Expert/Veeva Vault super-user.• Instructed Site Managers and LTM on appropriate use of CLIX and gave a short presentation on use of CLIX shortcuts for communicating effectively with sites.

• Screens and recruits patients into high-acuity clinical trials and non-interventional studies. • Engages with cancer research patients in outpatient clinic and inpatient admissions; coordinates and explains trial procedures to the subjects and families.• Regularly enters 50+ page case report forms with over 30 data points in 9 different electronic data capture systems. Resolves complex queries quickly and accurately.• Founded and oversees Give-Back Committee, providing the team with opportunities for team building and organizing team participation in charitable events in the community, including fundraising. • Edits and contributes changes to investigator-initiated oncology trial protocols under the oversight of the primary investigator. Contributes to the development/maintenance of study-specific case report forms and source document tools and the development of SOPs, best practices, and other research program documents.• Collects, reviews, and reports timely, valid, accurate study data for 15 + oncology trials. Obtains records required to complete case report forms in a timely manner, and retains essentials study source documentation. • Maintains accurate records for multiple observational trials. Keeps accurate records of visits and coordinates lab transfers with outside facilities. Works with internal audit teams to maintain FDA audit-ready files.• Facilitates study procedures for industry-sponsored and investigator-initiated clinical trials, from start-up to close-out, including the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.• Coordinates the conduct of complex (multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies and cellular therapies) Phase I – IV clinical oncology trials.• Trains new coordinators in the introductory period, and provides resources for less-experienced research staff.

Handles high call volumes with excellent customer service skills.Triages phone calls and hospital orders efficiently.Assist pharmacists with order entry, communication to multiple hospitals and researching medication management.Serves multiple facilities simultaneously with excellent attention to detail.Uses decision-making skills to prioritize and handle multiple critical tasks efficiently.

Researched Mental Health Parity laws and regulations, and how these regulations affect providers and patients in both Philadelphia and across the United States.Developed design thinking skills to affect change in mental health parity education.Researched behavioral health parity implementation for the Kennedy Forum to create an online aggregating and convening tool around behavioral health parityDesigned survey and analyzed data to gain information concerning behavioral health providers and the knowledge and interest in parity.Applied for IRB research approval and was accepted.Analyzed policy to determine best practices for providers surrounding behavioral health parity.Affected change in policies at local, state and federal levels using community-based skills.Developed insurance education tool that is used in Drexel graduate school curriculum, and is being used by the PA Insurance Commissioner to help guide an insurance literacy toolkit.Developed and disseminated effective communication strategies to impact policy at local, state, and federal levels using verbal, written and electronic mediaBuilt relationships with key community stakeholders to gather information concerning behavioral health practices, and built collaborative networks through key informant interviews

Managed inventory of long-term care pharmacy, including correct NDC upkeep within the computer system and securing best medication prices.Prepared oral, topical and compounded mediation promptly and accurately for the pharmacist to check.Packaged long-term care medications accurately in appropriate systems.Cleaned and maintained medication packaging systems (cassettes). Delivered medications as needed.Input refills within computer systems.

Interpreted and input new and refill prescriptions into computer system, requiring proficiency of medical abbreviations and terminology.Prepared oral, topical and compounded mediation for the pharmacist to check.Accurately handled money and cash drawer.Assisted customers and family members with pharmacy and over the counter medication related questions, triaging questions to the pharmacists as needed.Stocked over the counter medications.Assisted customers in finding best prices, discounts and medication manufacturer’s coupons for all medications.Provided excellent customer service and furthered the culture of trust by going above and beyond standard practices routinely.

Worked both for the hospital pharmacy in all technician positions and then at Family Medicine Residency as the prescription coordinator. Pharmacy responsibilities included:Compounding oral, topical and intravenous medications.Cross-training to work all positions and shifts, including billing, operating room and sterile compounding (intravenous medication) areas.Billing for OR medication charges.Filling Omnicell medication dispensing systems, including Anesthesia and Narcotic storage machines.Accurately performing Tech-check-Tech.Pharmacy Coordinator responsibilities included:Preparing accurate prescriptions for physicians to sign.Built network of retail and compounding pharmacies within local area.Providing friendly and efficient intermediary services between pharmacies, physicians and patients.Providing customer service to patients with medication refill requests, questions and concerns.Coordinating resources through the medication assistance program.Researching and providing resources for physicians when needed.Being a super-user that was responsible for coordination between electronic medical record system, and flow of prescriptions.Coordinating vacation coverage for physicians and residents.Cross-training within clinic and being proficient with other positions, including operator and scheduling positions.Assisting clinical staff with patient support.

Compounded oral, topical and intravenous medications. Cross-trained to work all positions and shifts, including Operating Room, Intensive Care Unit and Sterile Compounding satellites.Billed OR medication charges. Responsible for ordering OR Pharmacy satellite inventory.Assisted anesthesiologists with questions and special medication needs.Filled Pyxis medication dispensing systems, including Anesthesia and Narcotic storage machines.