Manager Clinical Research

K E V I N W. S N I E C I N S K I . Voice 415-***-**** · E-mail ***************@*****.***

PROFESSIONAL HIGHLIGHTS

20+ Years in Clinical Research, Clinical Trial Management, Clinical Data Management, Regulatory Submissions and Protocol Development

Experience at both site level and within Biotech

Site Management for Pre-Clinical, Phase I - Phase IV Trial Management experience, as a Senior CRA and CTM of National and Global Trials

Site Start-up Experience, including site selection, PI selection, staff training, CRA/CRO management, data integrity, protocol development and submissions, IRB/CHR

Cross functional experience, managing engagement with Regulatory Affairs, Trial Managers/CRAs, Legal, Materials & Logistics and sites

Therapeutic Areas include: Oncology/Hematology, Infectious Disease ( Hepatitis & HIV/AIDS specialist), Immunotherapy, Respiratory, Targeted Therapeutics, Rare and Orphan Disease and others

Clinical Monitoring with a strong understanding and application of ICH/GCP principles

PROFESSIONAL EXPERIENCE

THE Q Foundation

Clinical Operations Consultant – 6/18/19 to 2/15/20 (ended contract due to Covid-19)

Provided ICH/GCP compliant QA on all existing client files

Transitioned paper records in TMF to a new electronic system

Responsible for creation of draft SOPs

Creation of clinical trial data capture. through the creation of client surveys

Project management as needed

Support case management in the execution of organization contracts

QA on new client intakes

Aetna Pharmaceuticals

Clinical Operations Consultant – 12/15/18 to 6/15/19

ICH/GCP QA and client file organization

Restructured client data in compliance with National FDA regulations

Client consultations to evaluate medical need and Clinical Trial viability

Assisted in staff management, including completion of SOPs

Project management as needed

New staff on-boarding

AbbVie (Placed by InVentiv Health)

Study Management Associate III – 4/17 to 9/17 (40% reduction of staff including all contractors)

Matrix management of functional areas and/or study vendors to ensure clinical study execution occurred per timelines

Responsible for the drafting or red-lining of ICFs and other regulatory documents

Cross functional lead for protocol development from red-lining to finalization and submission

Escalated site and staff performance issues to management with possible solutions

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Assisted in the coordination of activities of a cross-functional team to ensure the initiation, conduct and completion of one or more clinical studies, Study time-lines and budget management within assigned study region(s)

Worked in study start up, cross-functional teams, team leads, legal, drug supply and quality control

Prioritized CRA/CRO activities to ensure study goals are met. This included development of data matrices, activities of site monitors, and data QA

Protocol preparation, investigator selection, site budget/contract development, investigator meetings, vendor selection & management, CRF design, specification review/approval, and monitoring oversight

Identified issues that potentially impact evaluable study data, ethical study conduct, ICH/GCP compliance and identify potential interventions or solutions to manage issues that threatened successful study execution

Achaogen (Placed by Kelly Services)

Senior Clinical Research Associate – 2/16 to 9/16

Managed 18 Global Study Sites and CROs/CRAs in the field of rare & orphan disease, respiratory and pain management

Assisted clinical operations management in the conduct of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs and ICH/GCP guidelines

Developed SOPs and Instructional documents relating to ICH/GCP efficacy within Clinical Trial Operations

Participated in planning, implementing, co-monitoring, and tracking clinical trials

Developed case report forms (CRFs), study documents, tracking tools, and study plans

Assisted in managing study start-up through close-out

Assisted CPM with document preparation for study site initiations including IVFs, contract and budget finalization, and other regulatory documents as needed

Established relationships with clinical study site teams, field monitors and Vendor staff

Responsible for staff compliance with protocols, SOPs, ICH/GCP guidelines and overall clinical objectives through CRO/vendor oversight; to include but not limited to: ensure complete, accurate, and current regulatory documents according to established guidelines including country-specific documents

Performed drug accountability (if assigned) and assure adequate documentation, storage, handling, dispensation, and return of Investigational Product

Ensured proper collection and storage of clinical trial supplies and samples

Provided written Q/A documentation of site visits (i.e. visits reports, letters to the sites, if assigned)

Resolved site-specific study issues by working with CROs/CRAs and any pertinent study personnel

Worked with data management to identify and resolve data discrepancies; review data listings for accuracy, consistency and trends and generate queries for any noted discrepancies

Bay Positives

Senior Clinical Research Associate – 6/14 to 1/16

Oversaw all Phase II through IV activity at site

Site Monitoring Oversight for established sites (3 to 7 sites) and approximately 200 patients

Site evaluation with lead investigators, for initiation of site start-up activity, assignment to appropriate protocols available within the NIH HIV Prevention Network

Worked with Site Principal Investigator to ensure sight submission were compliant with co-sponsor requirements.

Ensured RFI/RFP process was executed to the requirements of NIH Guidelines

Reviewed all applications and made preliminary assignments based on patient status & demographic data to the NIH and UCSF based on the parameters set forth within the community benefits research program

Identified core areas such as funding guidance, regulatory, ensured ICH/GCP compliance to ensure site preparedness, grant review made available through private and non-profit organizations

Worked to identify over 200 non-duplicated adolescents that would qualify for Infectious Disease Trials through NIH while partnering with numerous Bio-tech companies

Gilead Sciences, Inc.

Clinical Research Manager – 2/12 to 11/13

Managed approximately 100 Phase I – Phase IV Investigator Sponsored and Collaborative Protocols.

Site start-up, management of PI recommendations, negotiated with contracts and grants, regulatory document review, study drug management and overall maintenance of active sites

Monitored 2 Gilead Sites (2 Protocols – 12-18 subjects per site)

Therapeutic areas included HIV, HBV, HEP C and Oncology (numerous forms)

Reviewed and submitted all new protocols within department (between 3 to 12 monthly)

Study site start-up activities, while working cross-functional to execute all site contracts

Prepared new contracts in collaboration with Contract. Finance and Materials & Logistics

Chaired cross-functional collaboration between Legal, Contracts, Clinical Operations, Medical Affairs and Materials & Logistics

Worked on the implementation of a Phase IV Process Manual – Best Practices

Facilitated the Collaborative Grant review meetings with VP of Medical Affairs and Clinical Operations Managers

Publication management – Data-vision and internal document management

Drug supply and allocation for 50+ active sites

Site finance management for all sites and managed protocols

Provided site maintenance and updates to Clinical Operations and Medical Affairs

National Institutes of Health (NIH)

Senior Clinical Research Associate III – 6/06 to 1/12 / 50% Time (overlapped with UCSF role)

Management of approximately 8 to 12 Phase I – Phase IV Co-Sponsored Studies between sites and NIH.

Member of the National Leadership Committee, which reviewed and worked on partnership protocols (phase I through IV) with multiple bio-tech companies

Monitored 8 Active Sites with approximately 225 combined subjects

Clinical areas included Phase I – Phase IV HIV, HBV, Oncology/Hematology, Hepatitis C, Microbicide Trials

Reviewed and submitted all new protocols to local IRB/ICH (approximately 20 annually)

Prepared new contracts, coordinated efforts between sites and co-sponsors, material and logistics management, financial contracts and site start-up processes

Assisted sites with protocol submissions, per institution & NIH requirements.

Co-Chair of a cross-functional team between The Committee on Human Research, Clinical Operations, and Materials & Logistics

Managed Grant review meetings with Site PI and National Institutes of Health Leads

Attended quarterly meetings in Washington DC as Site Director quarterly

Presented site specific data and analysis as either lead speaker or in break outs.

Engaged all sites as Co-PI and/or Program Director based on protocol

Finance management for all managed protocols, 500k to 750k annually

Site monitoring maintenance (QA) and managed protocol meetings between Principal Investigators and sites

Managed the collection and training of computer-based data management into Remote Data Capture (RDC) & field data collection, using ACASI (Audio Computer-Assisted Self Interview) tablets. Process included some paper lead interviews for patient data collection

University of California, San Francisco -- Division of Adolescent Medicine

3/03 to 1/12 Analyst V – Program Director / Co-Investigator / 50% Time

Co-Investigator and manager for community based protocols

Developed viable ATN Network sites using Community Based Participatory Research (CBPR) research

Phase I - IV IRB/CHR submissions and changes as required

Site monitor for all NIH sponsored protocols, included monitoring for protocol compliance and timelines

Primary clinical areas included HIV, HBV, Hep C, Microbicide, Oncology

Created annual epidemiological rate maps for all relevant therapeutic areas, homicide, and homelessness in the greater San Francisco/Bay Area to identify high-risk populations, and to target gaps in available interventions

Provided support to Community Based Organizations (CBOs) in the areas of program development, participant management, service provider networking, fund-raising, grant writing and sponsor engagement

Successfully submitted and funded community grant applications for $450K, over the course of 4 years to benefit service organizations within my local NIH Network

Managed an annual venue based HIV rapid testing and HIV risk assessment, and linkage to care

Initiated a collaboration between the Department of Public Health and youth service providers to increase funding and programming based on community epidemiology mapping

Member of the NIH Community Leadership Group.

Managed all submissions of new protocols to IRB/ICH

Hired, trained and managed project staff and outreach staff for the NIH Adolescent Trials Network site (10 -18 staff members based on protocol need and budget)

NIH Publications

ATN 016A - Connect to Protect (C2P): Partnerships for Youth Prevention Interventions: Phase I

ATN 016B - Connect to Protect (C2P): Partnerships for Youth Prevention Interventions: Phase II

ATN 040 - Connect To Protect (C2P): Partnerships for Youth Prevention Interventions: Phase III

ATN 040b - Connect To Protect (C2P): Partnerships for Youth Prevention Interventions: Phase III - Changes in HIV-Related Risk among High-Risk Youth at Congregation Venues

ATN 041 M1 - Connect To Protect (C2P): MPowerment and PROMISE (CDC – DEBIs)

National Planning Leadership Committee (NIH) – Community Coordinator Representative. Appointment required me to review all Protocol Concept Sheets (PCS) being submitted to the various network leads for consideration; and protocol submissions

University of California, San Francisco - Adolescent Medicine – Publications

ATN 076 – Evaluation of an Intervention to Reduce Preventive Misconception in HIV Vaccine Clinical Trials, Protocol Team and Co-Investigator through UCSF

ATN 093 – CDC-ATN/NICHD Testing and Linkage to Care Project, Protocol Manager and Co-Investigator through UCSF

ATN 096 - Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults: Focusing on Young Men Who Have Sex with Men, At-Risk Latinas, and Intravenous Drug Users, Co-Investigator through UCSF

Author, Vaccine, Volume 33, Issue 11 - Adolescent decision making about participation in a hypothetical HIV vaccine trial - 2015

Author, The Journal of Prevention & Intervention in the Community - 2010 Challenges and approaches to mobilizing communities for HIV prevention among young men who have sex with men of color – 2006

Author, Ryan White Conference, Washington DC - HIV Basics, Thriving with HIV, HIV & Pregnancy, HIV Medications & Alternative Therapies – 2003

Author, Partnerships for Youth – Partnership Collaboration - XIV National AIDS Conference, Barcelona – 2002

Author, HIV+ gay men taking ART are more likely to have unprotected sex with discordant partners when using “party drugs” - 2002

Author, Psychological distress, not alcohol or drug use, associated with ART non-adherence” - National HIV Prevention Conference, Atlanta – 2001

Author, Adherence to HAART amongst alcohol and recreational drug users in San Francisco - 2001

Author, Alcohol, drug use and non-adherence to HAART - 2001

Boards and Volunteering

Event Coordinator – Volunteer, Bay Area Young Positives – 2008 to 2017

Special Events Coordinator and Consultant, Human Rights Campaign Annual Fund Raiser – 1997 – 2012 & 2016

San Francisco AIDS Emergency Fund Annual Gala – 2013 - 2015

NIH Community Planning & Leadership Committee, Community Chair – 2008 to 2012

Adolescent Trials Network Community Coordination Committee, Co-chair – 2005 to 2012

Gilead Collaborative Studies Review Board, Chair – March 2011 to November 2011

Downtown Youth Clinic – Volunteer Program Development Manager – 2004 to 2009

San Mateo HIV Services Executive Committee, Chair – 2005 – 2007

San Mateo County Health Services, HIV Prevention Planning Council, Chair – 2004 to 2007

Event Producer, Partnerships for Youth – Youth & HIV Symposium – 2003 to 2007

Executive Producer, The Destination Foundation’s Tails of the City HIV Fundraiser Event – 2002 – 2005

San Francisco County Health Services, HIV Prevention Planning Council, Member – 2004 to 2005

Event Producer, Launching of the Downtown Youth Clinic/EBAC – Oakland – 2003

Education

I have completed approximately 3 years of my BBA (Public Health Management), prior to being diagnosed with Cancer. At the time I was prepared to pursue the completion of my degree, my credits had lapsed. I continued in my career at UCSF and with the NIH, who saw fit to combine my educational experience and real-world experience as a sufficient knowledge base to continue my employment. I completed several course within the UCSF provided MPH Program to be promoted to Site Co-PI and Clinical Trial Manager.

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