Clinical Research Program Manager and SSU Lead

Shungu Nhema, MS, MHA, ACRP

*** *** ****** ***** ****

NC, 27519

Email: ***********@*****.***

Mobile: 601-***-****

Study Start Up/Maintenance Regulatory Manager/ICF Manager Biography

Clinical Research Professional with 18 years of Clinical Trials Research Experience Working as a Project Manager, Site Start up (SSU) and Maintenance Regulatory Manager, Informed Consent Writer/Reviewer and Clinical Research Study Coordinator in phase 1- IV clinical trials in accordance with FDA regulations, Good Clinical Practice Guidelines and ICH Guidelines. EDUCATION AND TRAINING

Masters in Health Care Administration and Management University of Phoenix 2007 to 2009

Master of Science in Sociology and Social Anthropology University of Zimbabwe 2002 to 2004

Bachelor of Science in Sociology

University of Zimbabwe 1999 to 2002

Indication/ Therapeutic area experiences include:

Oncology (Hematology, Lymphoma, Solid Tumor, Leukemia, Multiple Myeloma) Respiratory, Central Nervous System (CNS- (Depression, Schizophrenia, Bipolar), Neurology (Epilepsy, Stroke, Alzheimer’s, ADHD, Dementia and Parkinson disease. Substance Abuse, Immunology, Respiratory, Metabolism, Pain, Cardiovascular, Acute Coronary Syndrome, Planta Fibrosis, COPD, Heart Failure prevention, Chronic Heart Failure, Lateral Hip Pain, Cancer bladder, Total Knee Arthroplasty, Surgical Hemostasis, Obesity and COVID-19 among others.

Skills and Competences:

o Effective problem solving and critical thinking abilities o Effective communication and writing skills

o Strong organizational and time management skills; flexible and able to multi-task o Ability to work as part of a team, as well as independently o knowledge of IRB and human research protection regulations, including ICH GCP guidelines.

o Self-driven with heightened attention to detail. o Can work in a fast-paced environment with competing priorities. o Welcome constructive criticism, open to learning new approaches, and committed to continued career/professional growth.

o High level of general computing ability.

o Intermediate/expert level of function in all of the Microsoft Office applications, applications for team interconnectivity such as Microsoft Teams, Knowledge and/or experience working with web-based e-regulatory document management systems such as DocuSign, Devana, Clinical Research IO (CRIO), GoBalto, Clinical Trials Management System (CTMS), Clinergize, SharePoint, IVRS and Veeva Vault, FireCrest and SAE reporting platforms and IND safety report portals. o Subject matter expert in Shared Investigator Platform (SIP) Professional Experience

Regulatory Manager (Site Management Organization (SMO)) – (NextStage Clinical Research

(Houston, TX)

Remote- Cary, NC (Jan 2024-present)

o Managing regulatory in startup, maintenance through close out for all studies across the SMO network. Ensuring adherence to local, national, and international regulations and guidelines, as well as maintaining compliance with study protocols and sponsor requirements.

o Regulatory Compliance: Ensuring that all clinical trials conducted at sites are compliant with applicable regulatory requirements, such as Good Clinical Practice (GCP) guidelines, Institutional Review Board/Ethics Committee

(IRB/EC) regulations, and local regulations. This involves reviewing and interpreting regulations and implementing procedures to ensure compliance. o Regulatory Documentation: Maintaining and organizing regulatory documents and records in compliance with regulatory requirements (IRB submission and approvals for all sites across the network. Maintaining and updating the Investigator Site File (ISF) and Trial Master Files (TMFs), tracking, and filing regulatory documents for site staff, Sub Investigators and Principal Investigators- (GCP and HSP training records CVs, Medical license, 1572/Investigator Agreements, Financial Disclosure forms, Laboratory certifications and documents, site and Sponsor correspondence and managing document version control.

o Protocol Compliance: Ensuring that study protocols are followed accurately and consistently throughout the duration of clinical trials. Reviewing protocols to identify any regulatory or compliance concerns, providing guidance to investigators and study staff regarding protocol requirements, and conducting regular audits to assess protocol compliance.

o Adverse Event Reporting: Managing the reporting of adverse events and serious adverse events to regulatory authorities, sponsors, and ethics committees according to established timelines and guidelines. Ensuring accurate and timely documentation of adverse events and overseeing the preparation and submission of safety reports.

o Audit and Inspection Readiness: Ensuring that the research site is prepared for internal and external audits and inspections by regulatory authorities, sponsors, and/or third-party vendors. Conducting regular internal audits, coordinating external audits/inspections, addressing audit/inspection findings, and implementing corrective and preventive actions. o Training and Education: Training and education on regulatory requirements, guidelines, and best practices. This includes learning sessions, training materials and awareness of current regulations and updates. ICF Writer/Reviewer Manager: Contractor - Clinical Operations through Clinical Resource Network: Providing support to Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT) Remote- Cary, NC – (April 2023-December 2023)

o ICF Adaptation and Customization- As a primary writer, wrote the Main ICF and additional secondary ICFs to create country level ICFs for initial and Amendment submission to the central IRB and distribution to local IRB sites using the Clinical Trial Protocol, Investigator Brochure, Global Informed Consent forms and other related study materials

o Secondary Reviewer – As a secondary ICF writer, reviewed the ICFs written by the Primary writer and modified where needed to create final ICFs ready for Clinical Trial Monitor (CTM) approval

o Worked with CTM to make sure the ICFs are finalized for FDA and IRB submission and approval

o Made ICF revisions based on feedback from the FDA and IRB as needed o Filed the final approved ICFs into Trial Master File o Maintained an ICF tracker for both initial and Maintenance ICFs Site Start up and Maintenance Regulatory Manager: Contractor - Clinical Operations through Clinical Resource Network: Providing support to Boehringer Ingelheim Pharmaceuticals, Inc.

(Ridgefield, CT)

Remote- Cary, NC (Jun 2019-April 2023)

o Developed and compiled the regulatory document package and distribution to sites to meet project timelines.

o Developed the initial site start up and amendment documents package for central and local IRB submission

o Electronically and via a secure portal, distributed, reviewed, negotiated and released quality regulatory documents to meet study timelines. o Collected, reviewed and negotiated regulatory documents for investigator sites and maintained working files of Regulatory Documents- Study start up through study close out

o Made sure Regulatory Documents are ready for Sponsor Quality Control (QC) and audit at all times

o Send reviewed and approved quality regulatory documents to the "Clinical Trial Master File (Veeva Vault) in accordance with Sponsor SOPs. o Complied with all International Conference on Harmonization Harmonized Tripartite Guidelines for Good Clinical Practice ("ICH GCP Guidelines"), FDA Regulations & Guidance Documents, Sponsor SOPs and Working Instructions in reviewing and maintaining regulatory documents and Informed Consent Forms. o Attended study kick off meetings and study team meetings for assigned studies

(weekly and biweekly meetings) to discuss study progress and to provide detailed status of assigned studies and sites.

o Worked with assigned Investigator Sites to collect, negotiate and perform a quality timely review of regulatory documents per Sponsor’s SOP guidelines. SSU & Regulatory Specialist II

Syneos Health- Raleigh, NC (Jul 2017-May 2019)

o Point of Contact- Assumed responsibility as the Sponsor contact to ensure quality deliverables for country level and site level protocol submissions and approvals while working with research sites, IRB, FDA and other service providers

o Documentation Review- sent, collected, negotiated, review, filed (in Veeva Vault eTMF) and tracked regulatory documents to and from sites for site activation and maintenance through study close out. o SOPS and Work Instructions- Reviewed Standard Operating Procedures

(SOPs) and Work Instructions (WI) in a timely manner and kept training records updated accordingly.

o Submission Specialist- Worked with both local and central IRB and other local regulatory authorities on completing country level and site level submissions and approvals including Continuing reviews, Safety notifications (AEs, SAEs, IND Safety reports) and study closure notices to the IRB and research sites. o Local Investigator Contract and Budget Negotiator Support- Reviewed partial and fully executed budget and contract to make sure it matches the study level/site’s ICF language.

Regulatory Coordinator Tier 11

Duke Health- Durham, NC (Feb 2017- Jul 2017)

o In the Department of Oncology- Worked with 4 assigned Principal investigators

(PIs), supervising and maintaining regulatory and training logs and training records for 30+ sub investigators assigned to each PI o Prepared and maintained all regulatory applications and approvals from start up, maintenance to close out. Prepared (initial application, continuing reviews, protocol Amendments, AE, SAE and IND safety reports and close out notifications to the IRB).

o Maintained Regulatory Documents to make sure they stay current (CVs, HSP and GCP training records, Medical licenses, 1572s, Financial Disclosure Statements, Site delegation and training records, Laboratory certifications (CLIA, CAP, Lab Reference Ranges) and Imaging accreditation certificates o Prepared and completed Site feasibility questionnaires, involved in site Selection visits, Site Initiation Visits and Interim Monitoring Visits including Site Close out Visits with the CRAs

Project Manager II/ Senior Clinical Research Coordinator Wake Forest Baptist Medical Center- Winston Salem, NC (Nov 2014- February 13, 2017) o Pioneered research studies for Junior/entry level Principal Investigators on individual initiated and Industry initiated Clinical Trials and supervised Junior study coordinators

o Managed pediatric and adult epilepsy clinical trials o Prepared and submitted feasibility questionnaires, facilitates Pre site selection visits and close out visits with the CRAs and attended Investigator meetings. o Prepared study budgets with negotiation with the study sponsors o Prepared and maintained IRB documents (initial application, continuing reviews, protocol Amendments, AE, SAE reports and IND Safety reports) o Attended investigator meetings, prepared and attended Pre Site selection

(PSSV), IMV and Site close out visits

o Prepared and performed regulatory submissions to the Sponsor, IRB, DEA and FDA

o Developed study source documents, visit schedules and pre-screening questionnaires, administered research questionnaires, consented research participants and reviewed Medical Records

o Collected vital signs, EKGs, performed lab draws, processed and shipped lab samples, completed drug accountability and data entry and query resolution o Coordinated with various study providers worldwide. Project Manager I/ Clinical Research Coordinator

Precise Research Centers- Flowood, MS (May 2008- June 2013) o Recruited, interviewed, trained, mentored and supervised junior level CRCs and the study recruiters up to a team of 10 and conducted annual employee performance evaluation

o Completed feasibility questionnaires and facilitated pre-site selection visits, Site initiation Visits, routine monitoring visits and close out monitoring visits with the CRAs

o Assigned work tasks and communicated the expected timelines for each study trial and attended Investigator meetings and trained study staff o Managed study budgets

o Monitored Sponsor, IRB and FDA audits

o Prepared IRB submissions from start to close out o Managed Participant recruitment and management throughout the study o Performed Rating scales, collected vital signs and ECGs, performed drug accountability, phlebotomy tasks, handled lab processing and shipping Adverse event reporting, Data entry and query resolution

Regulatory Specialist/ Research Coordinator

University of Mississippi Medical Center - Jackson, MS - January 2007 to May 2008 o Completed feasibility questionnaires and facilitated pre-site selection visits, Site initiation Visits, routine monitoring visits and close out monitoring visits with the CRAs

o Maintained all regulatory documents for all clinical trials including training and certification of research staff.

o Responsible for all submissions to the IRB- initial, amendment, continuing reviews, adverse events, IND Safety Reports and close out submissions to both local and centrals IRBs for all protocols.

o Interviewed participants and caregivers including control groups. o Setup, operate and maintained research equipment and calibration records o Recruited participants, caregivers and healthy participants into clinical trials and conducted follow up visits throughout the study. o Responsible for taking vital signs, drug accountability, obtaining urine samples, monitoring adverse events, shipping laboratory samples, performing ECGs, data entry and query resolution per protocol requirements.

o Preparation of site initiation visits, monitoring visits and site close out visits o Primary Coordinator for oncology trials- Pain management in Cancer patients

o Back up Coordinator for Restless Leg Syndrome, depression, Bipolar and Schizophrenia trials

Assistant Lecturer

Women's University in Africa- Harare, Zimbabwe- June 2004 to January 2006 o Developed the teaching curriculum and course outline. o Set examinations and grade examination papers.

o Taught Sociology related courses

Research / Programs Assistant

Africare Zimbabwe - Harare, Zimbabwe- June 2003 to December 2004 o Worked with HIV infected patients, caregivers and HIV affected orphans in conducting interviews to gain knowledge of how to improve and help with the psychosocial and economic support.

o Designed research questionnaires, contacted interviews with participants and informants

o Data entry and performed data analysis and report writing Used Microsoft Excel, SPSS and Microsoft access

References available upon request.

Contact this candidate