Clinical Research Manager

Nasir Maniky

*** ******* ******, ****** ******, NY 10303

Mobile: 718-***-**** / Email: *******@*****.***

CLINICAL RESEARCH ASSOCIATE (CRA)

Over 1 year of experience in a clinical research organization (CRO) as a skilled CRA and a Clinical Data Associate (CDA) working on Phase II and III clinical trials.

Over 3 years of experience as a Clinical Research Associate working in a clinical setting.

AREAS OF EXPERTISE

•Ethics in Clinical Research

•Good Clinical Practice (GCP)

•Regulatory Requirements: FDA and Drug Control, Drug & Cosmetic Act

•Health Insurance Portability & Accountability Act (HIPAA)

•Therapeutic Experience: CNS Neurology

•Seizures

•Grand mal & Partial Seizure (epilepsy)

•Stroke

•Therapeutic Experience: CNS Analgesia

•Chronic Low Back Pain

•Monitoring Pre-study Visit, Site Initiation, Interim Visit & Site Close-Out

•Pharmacovigilance, Fraud & Misconduct

•Knowledge of Fortis and Oracle Clinical databases

•Microsoft Office Proficiency

•Reporting & Documentation

•Interpersonal & Communication Skills

•Fluency in Spanish

PROFESSIONAL EXPERIENCE

PRA HealthSciences - Clinical Research Associate I June 2016 – February 2017

•Plans day to day activities for monitoring of a clinical study and sets priorities per site

•Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites

•Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Company and Sponsor SOPs.

•Perform day to day In house monitoring tasks such as preparing regulatory document packs, perform quality control of completed documents, and maintaining TMF systems to upload completed and verified documents.

Premier Research - Clinical Research Associate II March 2015 – March 2016

•Collaborating on a Phase 3 Efficacy and Safety Study for Adjunctive Treatment of Major Depressive Disorder.

•Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations

•Plans day to day activities for monitoring of a clinical study and sets priorities per site

•Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites

•Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum

•Monitors with knowledge of quality/scope and budget parameters

•Escalates issues and feedback for the team

•Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase

•Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member

•Provides accurate and timely submission of trip reports

•Manages query resolution process with sites and Premier Research

Data Management

•Assists project team with assessing project feasibility and recruitment, as applicable

•Maintains project tracking system of subjects and site information as applicable

•Participates in Investigators’ Meeting as designated by Project Manager

•Manages investigative sites via telephone calls between visits

•Ensures adherence to study timeline and budget

•Attends meetings as required

•Performs additional duties and assignments, as requested

INC Research, LLC - Clinical Research Associate I July 2012 – December 2014

•Maintains timely and effective communications among team members and site staff

•Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Company and Sponsor SOPs.

•Maintains current regulatory documentation according to Essential

•Document Regulatory Guidelines (EDRG) and Trial Master File (TMF) plan.

•Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visit; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/ Serious Adverse Events (SAEs) and protocol violations; ensure proper storage, dispensation and accountability of all investigational Product(s) and trial related materials.

•Performs source data verification. According to contractual requirements. Assures timely completion of submission of Case Report Forms (CRFs) according to Clinical Monitoring Plan.

•Completes and submits visit reports according to SOP/Work Instruction requirements.

•Prepares for and attends Investigator Meetings; May present materials, as requested.

Aerotek Scientific Staffing - Quintiles CRO -Clinical Data Coordinator Overland Park Kansas April 2011 - December 2011

•Provided solid core and some comprehensive data management expertise to the data management team to provide efficient, quality data management products that met customer needs. Undertook team leadership activities under the supervision of the data team lead or functional manager.

NY Methodist Hospital - Research Study Coordinator June 2009 - March 2011

•Screened and recruited participants in insulin resistance intervention after recent stroke or transient ischemic attack.

•Tracked and maintained data entries into databases for patients with CVA related cases to monitor proper stroke management.

•Coordinated enrollment and randomization activities for eligible subjects and conducted annual as well as follow up visits.

•Coordinated clinical trial of FDA approved medicine for Adjunct therapy to help treat patients with partial –onset seizures while being on current anti-seizure medication.

NY Methodist Hospital - Research Assistant June 2007 – June 2009

•Testing of vestibular functions thru VNG tests and interpretations.

•Conducted insurance verifications for tested patients and referred for balance therapy.

TPS 360 - Business Development Associate July 2006 - June 2007

•Sales and Marketing of web-based recruitment business software to help companies facilitate their hiring cycle.

Delphi Strategic Solutions - Account Representative Sept 2004 - March 2006

•Screened and recruited applicants in various health professions

•Negotiated contracts, terms conditions and agreements to ensure proper length of employment.

Medplus Supplies - Account Representative Aug 2004 – Sept 2004

•Serviced existing and opened new accounts.

•Wholesaler of durable medical equipment / medical supplies for nursing homes, rehabilitation clinics, and independent pharmacies.

EDUCATION / CERTIFICATION

Universidad Autonoma de Guadalajara, Mexico July 1999 - May 2001

First two years of Medical School in Basic Sciences

State University of New York – Albany 1992 - 1997

Biology B.A., Minor in Psychology

Completed CITI certification and training for Biomedical Research

GCP Barnett Accredited 2011

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