Susan Leclair

Susan Leclair Email and Phone Number

Clinical Research Associate and CEO at West Coast Clinical Monitoring, Inc @
Susan Leclair's Location
Carlsbad, California, United States, United States
Susan Leclair's Contact Details

Susan Leclair phone numbers

About Susan Leclair

I am an experienced CRA with 31 years of Clinical Research Associate experience ranging from Field CRA to Lead CRA. As Lead CRA, I have worked closely with Sponsors to review/approve CRO study plans, provided oversight of the CRO team of CRAs, including report review and accompanied visits, and been part of the management team whose goal was to ensure a well-run study that is audit ready. I have worked with several CROs as well as Sponsors as both employee and contractor, and have worked directly with Sponsors as Lead CRA in oncology, rare disease and hepatitis. My therapeutic expertise also includes organ transplant, immunology, women’s health, infectious disease and device trials. As the Founder and CEO of WCCM, I work with a small group of seasoned (5-20+ years) CRAs who can be available through WCCM if additional CRA resourcing is needed.

Susan Leclair's Current Company Details
West Coast Clinical Monitoring, Inc

West Coast Clinical Monitoring, Inc

Clinical Research Associate and CEO at West Coast Clinical Monitoring, Inc
Susan Leclair Work Experience Details
  • West Coast Clinical Monitoring, Inc
    Ceo, Independent Clinical Research Consultant
    West Coast Clinical Monitoring, Inc 2012 - Present
    March, 2018-Present:• Primary/Lead CRA on Hepatitis C device trial• Perform site monitoring nationwide at all participating study sites• Work directly with Sponsor management team to review and approve subject eligibility, re-develop database and CCGs, institute recruitment initiatives and create study management tools• EDC: ClinSparkJuly, 2017-Present:• All aspects of monitoring for Phase 2 Metastatic Breast Cancer Study• Responsible for regulatory reconciliation of central oncology network • Prepare study sites for Sponsor audits and regulatory inspections• Assist in database reconciliation in preparation for study closure• EDC: InForm February, 2017-Present: • All aspects of monitoring for Phase 2 Recurrent Glioblastoma study and Phase 2 study in lung cancer with brain or leptomeningeal metastasis. • Work directly with Sponsor to review and approve subject eligibility• IMV training of in-house CRAs.• EDC: InForm October, 2016-October, 2017: • CRA for phase 2 solid tumor metastatic cancer trial combining monoclonal antibody with TKI in the following select tumor types: endometrial, urothelial, head and neck, renal cell and melanoma.• EDC: InForm2014-2017: • Primary CRA for Phase 1b and Phase 2/3 pancreatic cancer trials • Work closely with Clinical Trial and Data Managers to produce protocol amendments, develop database, interact with vendors, train CRO personnel and perform CRC training at Investigator Meetings • Provide on-site training to members of pharmaceutical company to enhance awareness of site staff and CRA activities during IMVs• Nationwide monitoring of all participating study sites• Perform PSSV, SIV, IMV and closeout visits2012-2014:• All aspects of monitoring for two multicenter, Phase 2 breast cancer trials• All aspects of monitoring for Phase 1 dose escalation oncology study • All aspects of monitoring for multi-center, pivotal device study• Performed interim monitoring visits for Cystic Fibrosis study
  • Dsp Clinical Research
    Senior Clinical Research Associate
    Dsp Clinical Research 2011 - 2012
    • Performed all aspects of monitoring for Phase 3 urology and birth control studies• Performed QA audits for closed and ongoing trials• Conducted interim and close out monitoring visits• Produced comprehensive visit reports and status reports
  • Clinimetrics (Name Change To Omnicare In 2010)
    Senior Clinical Research Associate
    Clinimetrics (Name Change To Omnicare In 2010) 1997 - 2011
    • Identification of potential investigational sites• Coordinate and perform comprehensive site management for Phase 1-IV clinical trials• Conduct pre−study, initiation, interim and close out monitoring visits• Communicated with sponsors, sites, and colleagues to ensure effective project management.• Performed PK monitoring• Audited study sites on behalf of sponsor company• Performed mentoring/co−monitoring to junior CRAsProjects/Indications: Phase I/II treatment of solid tumors, Phase II treatment of metastatic lung cancer, phase II/III prevention of staphylococcal sepsis in very low birth weight infants, Phase III immunosuppressive medication for kidney transplant subjects, Phase II prevention of Graft versus Host Disease following stem cell transplant; Phase III treatment of nocturia, Phase 1 Bioavailability and Bioequivalence PK monitoring, Phase II treatment of non-Hodgkin’s lymphoma, Phase II treatment of breast cancer, Phase III treatment for chronic pain, Phase II/III treatment of rheumatoid arthritis, Phase 1 PK monitoring, Phase lll treatment of bacterial skin infections, Phase ll treatment of stress urinary incontinence.
  • University Of California, San Diego
    Nurse Practitioner
    University Of California, San Diego 1997 - 1999
    • Provided primary gynecologic care to female patients• Diagnosed and treated menstrual, breast, and genito-urinary tract disorders• Provided contraceptive counseling and management• Diagnosed and treated sexually transmitted diseases
  • Parexel
    Clinical Research Associate
    Parexel 1991 - 1997
    Durham, North Carolina, Us
    • Primary CRA for a multi−center, international cardiovascular study• Tracked timelines and study progress, coordinated monitoring activities for CRAs, reviewed trip reports and correspondence• Conducted pretrial visits and assisted with site and investigator selection; performed all aspects of site monitoring, from qualification visits through termination visits• Mentored new CRAs, participated in CRF and protocol development, and managed 11 sites involved in three different protocolsTherapeutic Areas: Cardiovascular, Immunology/Infectious Diseases, Oncology, Neurology, OB/GYN and Transplantation
  • United States Air Force
    Obstetric Staff Nurse, Lieutenant
    United States Air Force 1987 - 1990
    Randolph Afb, Tx, Us
    • Provided care to antepartum, intrapartum, and postpartum patients as well as to newborn infants• Oriented new personnel and in−serviced medical staff

Susan Leclair Skills

Clinical Research Clinical Trials Cro Oncology Protocol

Susan Leclair Education Details

  • University Of Washington
    University Of Washington
    Adult Primary Care And Women'S Health Care Nurse Practitioner Pogram
  • University Of Massachusetts Amherst
    University Of Massachusetts Amherst
    Nursing
  • University Of Washington
    University Of Washington
    Ob Gyn/Adult Primary Care Nurse Practitioner

Frequently Asked Questions about Susan Leclair

What company does Susan Leclair work for?

Susan Leclair works for West Coast Clinical Monitoring, Inc

What is Susan Leclair's role at the current company?

Susan Leclair's current role is Clinical Research Associate and CEO at West Coast Clinical Monitoring, Inc.

What is Susan Leclair's direct phone number?

Susan Leclair's direct phone number is +176093*****

What schools did Susan Leclair attend?

Susan Leclair attended University Of Washington, University Of Massachusetts Amherst, University Of Washington.

What skills is Susan Leclair known for?

Susan Leclair has skills like Clinical Research, Clinical Trials, Cro, Oncology, Protocol.

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