Clinical Trial Manager II

• Oct 2022 - Present

• Responsible for the global management of assigned clinical trial(s) including leading cross functional teams in study start-up activities, contract and budgeting, patient recruitment and enrollment, safety, etc. • Serves as the clinical trial point of contact and liaison between the CRO/vendors and Cook MyoSite. • Responsible for tracking and achieving study timelines and milestones, providing appropriate vendor management and oversight, delivering regular internal/external team communications, and handling identification and escalation of issues. • Represents Cook MyoSite as the expert on the AMDC product, clinical trial procedures, clinical landscape, disease state, anatomy, and processes with outside vendors and internal teams. • Responsible for implementation and oversight of assigned clinical trial(s) Trial Master File (TMF) for inspection readiness. • Serves as a resource for the Product Management team (PM) by providing clinical trial metrics that aide in production forecasting and providing product feedback as needed. • Helps to identify potential new clinical site relationships and maintain a database with contact information. • Develops an understanding of the complex scientific concepts regarding the AMDC product and the proposed mechanism of action to comprehend highly detailed scientific data and scientific publications. • Presents monthly updates and annual business plans to Clinical Affairs Manager and other stakeholders. • Travels to national professional meetings as a representative of Cook MyoSite, as needed. • Assists as requested in the preparation and follow up of internal process audits, vendor and/or clinical site quality audits as well as regulatory inspections. • Assists with the planning of Investigator Meetings. • Assists with the negotiation and management of clinical trial budgets and clinical trial documents. • Assists with mentorship and training of CTMs and/or other Clinical Development roles, as requested. Show less

Mortgage Loan Officer

• Apr 2022 - Present

Clinical Research Project Coordinator

• Jan 2022 - Oct 2022

• Single-handedly created and implemented a standard procedure for emergency use of investigational medications and devices at Denver Health• Performed all responsibilities of research associate (see below) in addition to the following:• Clinical Trial project manager for two vascular biologic FDA studies sponsored by Humacyte Inc.• Project coordinator and manager on several Traumatic/Surgical Clinical Trials ranging from sponsor-investigator to investigator-initiated studies.• Managed Clinical Trials from regulatory and financial start-up study design to active enrollment inresearch procedures.• Worked with finance department to track budgets and direct invoicing appropriately during trial execution• Worked with multiple teams (surgeons/clinical staff, CROs, Sponsors, vendors, billing, grants/contracts department) to ensure proper execution of clinical trials• Data collection and management for various Trauma Surgery research projects.• Monitored in-house and multi-site research activities and document to comply with FDA clinical trial regulations.• Developed effective SOPs for research compliance and good clinical practice for Trauma Surgeryresearch department.• Worked alongside the grants and contracts department to manage study budgets and research effort for surgery research department staff.• Maintained IRB and regulatory documents according to FDA and clinical research guidelines• Processed, stored, and shipped biospecimens per protocol and safety requirements Show less

Clinical Research Associate

• Apr 2021 - Jan 2022

• Managed and performed primary clinical research coordinator duties for FDA clinical trial• Ensured site compliance and made suggestions for process improvement• Screened patients, confirmed eligibility, performed follow up visits, and provided assistance during patient surgery• Reviewed cases and managed data for research databases pertaining to traumatic injuries• Reported and documented safety issues such as adverse and serious adverse events• Oversaw study-specific site inventory to ensure sufficient supplies are on site for clinical trials• Captured and managed patient data into specific data software required by each study (e.g. iMedidata,REDcap, Media, Excel)• Oversaw execution of study monitoring while ensuring site productivity and quality Show less

Clinical Research Coordinator

• Sep 2018 - Jan 2021

• >4000 hours of direct patient care in clinical trials; test new medications for patients with dermatological conditions (e.g. eczema, psoriasis, vitiligo, alopecia, hidradenitis suppurativa, prurigo nodularis) • Assist Principal Investigator during procedures (e.g. biopsies), skin assessments, and adverse event/ concomitant medication evaluations • Lead patient visits under the supervision of Principal Investigator: perform ECGs, tape stripping, swab sample collection, and subcutaneous injections; collect vitals and medical history; discuss study procedures and adverse events; and dispense medications/instructions for use • Serve as the primary point of contact in >15 research studies; including recruit, educate, and communicate with patients and research team • Perform all study procedures and visits according to specific study protocols • Address data queries per Good Clinical Practices and assist with external and internal audits Show less

Quality Control Microbiologist

• Aug 2016 - Aug 2018

Microbiological and chemical assays (membrane filtration, media testing for release, pipetting, nitrate and Total Organic Carbon testing), training new employees, safety compliance and regulations manager within the microbiology department, sampling of raw materials and environmental monitoring, cGMP gowning into controlled areas, data entry and interpretation. Microbiological and chemical assays (membrane filtration, media testing for release, pipetting, nitrate and Total Organic Carbon testing), training new employees, safety compliance and regulations manager within the microbiology department, sampling of raw materials and environmental monitoring, cGMP gowning into controlled areas, data entry and interpretation.

Medical Assistant/Receptionist

• May 2012 - Sep 2015

Review of electronic charts, preparation of exam rooms, patient check-in, collection of vitals and medical background, assistance in injection procedures, co-managed front desk, multi-lined phones, payment collection, insurance pre-authorizations, eClinical computer software, communication with patients/doctors/family members/other medical facilities. Review of electronic charts, preparation of exam rooms, patient check-in, collection of vitals and medical background, assistance in injection procedures, co-managed front desk, multi-lined phones, payment collection, insurance pre-authorizations, eClinical computer software, communication with patients/doctors/family members/other medical facilities.

Dog Trainer

• May 2014 - Aug 2014

Trained small and large dogs under supervision of certified animal trainers, puppy socialization and basic training, assisted in 6 week training program for beginner/intermediate dog training. Cleaned facility, assisted owners in forming a training routine and tips. Trained small and large dogs under supervision of certified animal trainers, puppy socialization and basic training, assisted in 6 week training program for beginner/intermediate dog training. Cleaned facility, assisted owners in forming a training routine and tips.

Administrative Assistant

• 2009 - 2012

Scanning, filing, labeling important and confidential documents (e.i. insurance, lab/test results, medical history, patient forms), Microsoft Office, assistance for all employees by completing miscellaneous tasks and errands. Scanning, filing, labeling important and confidential documents (e.i. insurance, lab/test results, medical history, patient forms), Microsoft Office, assistance for all employees by completing miscellaneous tasks and errands.