Mark Sprenz

Experience

• 

  United States Marine Corps

  Jan 1993 - Mar 2013

  • Provided leadership to the three regional training centers consisting of 24 Marines, 28 contracted instructors and support staff, and three civilian government employees• Coordinated supply, logistical, and administrative needs between the Communication Training Centers and the overarching Marine Corps Communications and Electronics School’s leadership• Completed monthly reports• Prepared slide presentations and statistical data for information and planning briefs• Responsible for $1.2 million Information Assurance (IA) voucher budget, which included the purchasing, managing, and issuing of IA vouchers • Coordinated, planned, and scheduled training events throughout the United States to meet unit specific training outside the regional training centers• Responsible for briefing the Communication Training Center’s history, current statuses, and future developments to policy and decision makers• Directed weekly telephone meetings• Responsible for strategic planning and the development of future academic curriculum Show less • Planned, implemented, and supervised all tactical radio networks• Provided leadership, mentorship, and professional development to 30 Marines• Accountable for and proper storage of 850 cryptographic controlled items• Responsible for proper safeguarding, handling, storage, and destruction of classified cryptographic material in accordance with Department of Defense and Department of the Navy regulations• Managed the preventative maintenance records and accountability of 1500 radio communication items Show less • Developed professional relationships throughout the community to include high schools, community leaders, and community programs • Projected positive community outreach and marketing of the Marine Corps • Developed and executed daily, weekly, and monthly independent work plans• Consistently achieved monthly canvassing goals and sales objectives• Accurately completed enlistment packages in accordance with Marine Corps regulations• Briefed high school students, faculty, and community leaders on the benefits of the Marine Corps experience Show less

  • Warfighter Training Support Branch, Staff Noncommissioned Officer in Charge

    Oct 2011 - Mar 2013

  • Radio Chief’s Course/Field Radio Operator’s Course Chief Instructor

    Oct 2010 - Oct 2011

  • Battalion Level Radio Chief

    May 2005 - Oct 2010

  • Marine Corps Recruiter

    Jan 2002 - May 2005

  • Multichannel Radio Operator

    Jan 1993 - Dec 2001
• 

  Clinical Research Management, Inc. (ClinicalRM)

  Jan 2015 - Jan 2017

  • Management of logistical and operational support to standup, operate, and maintain clinical trial sites and associated clinical and laboratory infrastructure.• Provided strategic planning, business development, relationship development, and proposal efforts, subcontracting and marketing.• Experienced at managing and developing local staff consisting of clinical professionals, researchers, engineers, and operational personnel.• Ensured that the client’s goals and expectations were met and was personally responsible for the overall satisfaction of the customer• Acted as the primary contact for the client and for all internal supporting functions.• Acted as the conduit for the in-country staff and project managers to the Program Managers and Executive team.• Provided GCP, protocol, and study specific training to the research staff.• Provided mentorship and leadership to the research staff in Sierra Leone and Liberia.• Assisted with the development of standard operating procedures (SOPs) in Sierra Leone and Liberia.• Worked as part of a multinational team to implement the EBOVAC-Salone vaccine study with Janssen Pharmaceutical in Sierra Leone.• Lead the submission process in Sierra Leone for all study related materials to the regulatory bodies in Sierra Leone for three clinical trials• Worked closely with the logistical groups and the MOH in Sierra Leone to obtain importation certificates for the investigational product, essential medicines, and study materials.• Worked closely with the logistical and operational groups with material transfer agreements for study related samples. Studies:• Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2• Ebola_CP: Convalescent Plasma for Early Ebola Virus Disease in Sierra Leone• EVD 002: Collection of Ebola Virus Disease (EVD) Convalescent Plasma; Longitudinal Cohort of Ebola Survivors Show less

  • Manager, Global Infrastructure Development

    Jan 2015 - Jan 2017

  • Associate Program Manager

    Jul 2015 - Dec 2015

  • Site project Manager

    Jan 2015 - Jul 2015
• 

  Duke Raleigh Hospital

  May 2016 - Oct 2017

  Emergency Room Registered Nurse

  • Responsible for the assessment, specialized care, safety, and management of up to four patients in a community based critical care environment.• Perform focused assessments, coordinate care, and triage patients in accordance with the Emergency Severity Index (ESI) guidelines.• Provide patient education in support of medications and adherence; diagnoses and disease processes; and instructions on after discharge care and follow up medical care.• Orient, train, and precept new nursing staff and emergency medical service students to the emergency department and the policies and procedures of the department.• Serve as the emergency departments committee chair on stroke for the hospital. Show less

• 

  Duke University

  Oct 2017 - Mar 2020

  Research Nurse Coordinator

  In my role as a CNRC, I was responsible for the overall coordination of multiple clinical research studies conducted by a supervising physician. My duties included: • Screening• Consenting• Providing staff and participant training• Maintain and inventory study related supplies • Providing training to new study staff in accordance with the protocol, GCP, and HSP guidelines• Abstracting data from charts, records and interviews • Obtain study related samples for laboratory analysis• Assist with the development of Manuel of Operations • Assist with the regulatory documentation and maintaining study regulator binders• Assist with submission of study documents to Institutional Review Board (IRB)• Work with the study monitor to conduct monitoring visits Studies:• Profiling Biomarkers to Characterize and Predict Posttraumatic Epilepsy Following Traumatic Brain Injury• SIGMA - Predicting Risk of Infection using Sensor and Molecular Measurements (PRISMM) Family Study• Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness-Coordinating Center• Molecular and Epidemiological Study of Suspected Infection (MESSI)• Phase 1/2 Placebo Controlled, Partially-Blinded Clinical Trial to Assess the Safety and Efficacy of Microbial Restoration by Enema with Banked and Thawed Processed Stool in Individuals with One or More Recurrences of Clostridium Difficile Associated Disease • Targeted Reduction of Antibiotics Using Procalcitonin in a Multi-center, Randomized, Double-Blinded, Placebo-Controlled Non-Inferiority Study of Azithromycin Treatment in Outpatient Adults with Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level of ≤0.25 ng/mL (TRAP)• Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety, and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older • Host-Derived Biomarker Signatures for the Diagnosis of Acute Rickettsial Diseases Show less

• 

  Duke Raleigh Hospital

  Oct 2018 - Mar 2020

  Clinical Nurse II PRN

  • Responsible for the assessment, specialized care, safety, and management of up to four patients in a community based critical care environment.• Perform focused assessments, coordinate care, and triage patients in accordance with the Emergency Severity Index (ESI) guidelines.• Provide patient education in support of medications and adherence; diagnoses and disease processes; and instructions on after discharge care and follow up medical care.

• 

  FHI Clinical Inc.

  Mar 2020 - Mar 2022

  In my role as a CTM, I was responsible for the day-to-day management of clinical projects, including direct communication and interaction with clinical sites, CRAs and third-party vendors. My duties included:• Provide cross functional leadership and oversite• Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant.• Collaborate with the Project Manager in order to prepare, organize, and present investigator meetings.• Deliver documents and study materials for the clinical department in a timely manner.• Perform reviews of monitoring visit reports and confirm alignment with timeline.• Support clinical trials as needed in order to measure performance and ensure duties are met.• Establish and maintain the tracking tools for assigned trials, including project files both electronically and in the Trial Master File and Project Status Reports.• Proactively identify and resolve issues and participate in process improvement initiatives.• Develop and track study timelines, and quality metrics.• Manage study investigators, study sites, clinical monitors.• Conduct regular meetings with clinical, quality, and regulatory teams to assess and mitigate emerging or potential risks.• Collaborates with study team to ensure data milestones are met. Show less • Acted as Subject Matter Expert for the Oracle Siebel for the CRA staff, provided assistance and training on the Clinical Trial Managment System (CTMS). • Assist in the preparation of routine protocols, informed consents, SOPs, and other appropriate documentation.• Monitor clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines (may be done with Lead CRA/assessor/supervisor as part of assessment period).• Coordinate necessary activities required to set-up, monitor, and close-out clinical trials sites.• Conduct site assessment, initiation, routine, and close-out monitoring visits (may be done with Lead CRA/assessor/supervisor as part of assessment period).• Complete accurate monitoring visit reports.• Develop training materials and conducts training for study implementation based on company policies and SOPs.• Contributes to the development of and implements protocols and informed consents for research studies.• Provide guidance on any protocol related issues.• Manage budget for task assigned are completed as per expectation• Develop, review, and maintain key study documents to ensure adequate resource and reference documentation.• May serve as a liaison with internal and external partners to ensure effective collaboration efforts.• Oversee planning of meetings, site visits, and drafting necessary documents.• Ensure compliance with government regulations when /if contributing to protocols, analysis plans, reports, and manuscripts.• Provide input with questionnaire development, analysis, study design, and material management. Show less

  • Interim Clinical Team Manager

    Aug 2021 - Mar 2022

  • Clinical Research Associate

    Mar 2020 - Mar 2022
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  UST Clinical LLC

  Mar 2022 - now

  Senior Clinical Trial Manager

  In my role as a CTM, I am responsible for the day-to-day management of clinical projects, including direct communication and interaction with clinical sites, CRAs and third-party vendors. My duties included:• Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant• Deliver documents and study materials for the clinical department in a timely manner. • Perform reviews of monitoring visit reports and confirm alignment with timeline.• Support clinical trials as needed in order to measure performance and ensure duties are met.• Establish and maintain the tracking tools for assigned trials, including project files both electronically and in the Trial Master File and Project Status Reports.• Proactively identify and resolve issues and participate in process improvement initiatives.• Develop and track study timelines, and quality metrics.• Manage study investigators, study sites, clinical monitors.• Conduct regular meetings with clinical, quality, and regulatory teams to assess and mitigate emerging or potential risks.• Collaborates with study team to ensure data milestones are met. Show less