Analyzes incoming clinical trial activation requests and provides recommendations to investigators for budget development, clinical operations resources, regulatory support, and pre-award contracting; Identifies and selects expert content reviewers for scientific protocol review, analyzes and collates reviewer comments for consistency, and clarifies outstanding questions from the investigators; Assesses clinical trial protocols for feasibility of study design and adequate resources for study execution, including sufficient budget, staff, and equipment; Provides recommendations to investigators to improve success of study implementation and conduct; Evaluates applications for the CRS voucher funding program for scientific merit and facilitates approval and account establishment for voucher awardees; Reviews investigator requests to utilize ResearchMatch to verify institutional and regulatory compliance with human subjects’ research; Develops standard operating procedures and training videos for clinical research harmonization efforts

Supervised and trained a team of 9 research personnel to ensure clinical trial study procedures were followed as described in the protocol and in compliance with GCP/ICH, state, and institutional policy. Served as the primary contact for subjects, study personnel, Institutional Review Board (IRB) and study sponsor;Supervised pre-award, study activation activities, and regulatory coordination of over 25 investigator-initiated and industry-sponsored clinical trials activities;Developed data collection instruments and managed data repositories. Conducts quality checks to ensure integrity of data collected. Performs study analysis, collects pertinent information from study participants through interviews, administration of tests, or surveys, or questionnaires, and medical records review;Manages financial aspects of clinical trials. Authorizes expenditures, monitors status and reconciles budget to ensure compliance with fiscal guidelines and regulations. Prepares financial reports and manages ongoing purchasing activities;Serves as the primary liaison between sponsor program officers and the dermatology clinical trials program;Writes grant proposals. Collaborates with investigators to develop research proposals. Interfaces with funding and regulatory agencies to exchange information;Prepares and submits timely, accurate, and complete documentation of study continuing review and study amendments to Institutional Review Board (IRB);Develops essential study documents such as study protocols, informed consents, and case report forms Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies;

Supervised coordination of all activities related to PCORI-funded project;Coordinated recruitment and retention efforts for 300 participants from 3 performance sites nationwide;Designed and managed data collection through REDCap survey instrument;Wrote study protocols, informed consent forms, and IRB applications;Managed study budgets, invoices and financial reports;Served as the primary liaison between PCORI program officers and institution;Authored quarterly reports detailing recruitment numbers and projections, engagement activities, and updates on project progress;Trained, supervised, and mentored 4 research study personnel

Designed and implemented data collection tools and surveys for the Rapid Prototyping for HPV Vaccine Delivery protocol;Oversaw the logistics of the research study with activities such as instrument development, data collection, and record-keeping;Recruited and retained over 100 participants;Gained experience with prototype development, IRB submission and post-study analysis

Collected and prepared samples for shipment to the NIH biorepositories adhering to protocol and IATA requirements;Co-developed an international survey for parents of children with PKD;Conducted outreach and participant recruitment by contacting potential participants, pre-qualifying them, explaining the study and scheduling study visit;Served as a credentialed, backup study coordinator for PKD studies at University of Colorado Hospital

 Managed and delegated shop responsibilities Evaluated staff performance Maintained inventory Retained and evaluated detailed records of supplies and stock orders Handled all customer service issues and complaints