06/19/09
G. KARTHIKEYAN
Edison, NJ
Email: r1336@bio-link.org
Date Available:
7/1/2009
Location Desired:
Anywhere in US
Objective:
Monitoring clinical trial and acheving companies objects.
Education:
Master of Pharmacy, Tamil Nadu Dr. M.G.R Medical University, India - 2003
Bachelor of Pharmacy, Tamil Nadu Dr. M.G.R Medical University, India - 2001
Biotechnology Skills:
 6+ years of progressive Clinical Research experience in Oncology and Endocrinology
 Excellent knowledge of GCP/ICH guidelines and FDA regulations
 Experienced working on EDC trials(Inform and Oracle) and tracking query resolution
 Effective clinical monitoring skills that include conduction of site initiation, monitoring and close out visits
 Expertise in designing CRFs and protocol development
 Experienced in reviewing the CRF forms for completion and correction according to sponsor’s policy and CRF guidelines
 Expertise in evaluating and selecting potential investigators who can proficiently conduct the clinical trials through Site Feasibility Questionnaire, telephonic screening and onsite visit
 Proactively identify solutions when issues arise and resolve by using well-developed problem-solving skills
 Proficient in study planning activities, developing study time line (IRB and Regulatory approval, designing CRF, Patient recruitment) updating Investigational Brochure, Planning and conducting investigator meetings
 Preparation of Interim reports and Follow up letter for all kind of visits and submit to Sponsor
 To ensure all AE and SAEs are reported promptly.
 Experience in Handling BA/BE studies(Dose escalation, Food affect Bio availability and PK&PD)
 Well organized, team player, strong work ethics and committed to achieve study objectives
 Excellent communication skills-oral and written; good interpersonal and leadership skills including team building & team development skills
 Willing to travel extensively
Work Experience:
PROFESSIONAL EXPERIENCE
Nectid Pharmaceuticals Apr 2008- Present
Lead Clinical research Associate
 Responsible for managing approximately 12 sites - performing IMV, PSSV, SIV and SCV according to applicable ICH GCP, SOPs and FDA guidelines.
 Implementation activities including leading team meetings, CRA oversight, vendor management and ongoing study progress.
 Assist the Regulatory Department in the preparation of regulatory submission packages according to local regulations
 Negotiate site contracts as requested by Project manager
 Ensure proper handling and delivery of study supplies, biological samples and Investigational product
 Assisted in the supervising of field monitors and perform the activities of planning, motivating, managing and tracking clinical trials
Clinical Trial Experience at Nectid
Oncology : A Multi-Center, Open Label Study of Efficacy and Safety of Inhalational Cytotoxic agents administered through Nebulizer in Treatment of Patients with Relapsed/Progressive Osteogenic Sarcoma Metastatic to the Lung.
Oncology :Study for Phase-II Clinical Trials for Investigational drugs, a multi-component immunotherapy for preventing cancer progression, and a vaccine for melanoma(Skin cancer)
Oncology : Open-label phase II study evaluating the safety and efficacy of Study drug in patients with wild-type KRAS status as first-line therapy in subjects with metastatic colorectal cancer.
Endocrinology:A 4-month, multicentre center, open label study to find the safety and efficacy of oral insulin given as split doses before and after meals in subjects with type-1 diabetes mellitus maintained on insulin therapy.
Endocrinology:A prospective, open, randomized, comparative, 3-arm, parallel study to evaluate the efficacy and safety of fixed dose combination of dipeptidyl peptidyl peptidase-4 inhibitors in patients with type 2 Diabetes Mellitus on stable dose of a sulfonylurea.
PPD Inc. July 2006 â€"Mar 2008
Clinical Research Associate-II
 Working closely with development team members, clinical site personnel, and external vendors to achieve the company goals
 Manage various activities associated with the implementation and conduct of clinical trials
 Conduct site training of protocol and operational requirements to ensure compliance with the protocol, SOPs and regulatory requirements for GCP
 Monitored the progress of ongoing clinical studies through frequent contact with the study sites, by telephone and through monitoring visits
Clinical Trial Experience at PPD
Cardiology: Multicentre, Active Controlled, Randomized, Double-Blind, Parallel Arm Study of Study Medication in Nonvalvular Atrial Fibrillation
Infectious Diseases: Multicentre, Randomized, Phase 4, Long-term Outcomes Associated for Patients with Chronic HBV Infection
Infectious Diseases :A Randomized, Phase II, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Investigational products in Combination With Other Antiretroviral Drugs for HIV patients
Oncology: Multicentre, Phase 3, Randomized Study of the Efficacy and Safety of Study Medication in Metastatic Pancreatic Adenocarcinoma.
Oncology:Non Small Cell Lung Cancer Phase I and II(A Phase I-IIa Dose-Ranging Study of investigational drugs in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC) patients
Endocrinology :A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of Study drug and oral Antihyperglycemic in Subjects(1540-Global) with Type 2 Diabetes
Endocrinology :A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of Study drug plus oral Antihyperglycemic or Study drug Alone in Subjects(1500-Global) with Type 2 Diabetes
Endocrinology :OLE Study : Open lable Extention study to Investigate the long term safety of the Investigational drug Study Drug in subjects with Type II Diabetes.
Glenmark Pharmaceuticals ltd Feb 2005 â€"July 2006
Clinical Research Associate
 Managing and monitoring Phase I, Dose escalation, Bioavailability and Bioequivalence, Pharmacokinetic Pharmacodyanamic and Food affect Bioavailability studies (Approx 65) on Healthy human subjects and patients in different therapeutic area.
 Responsible for performing drug accountability and reporting SAE/AE promptly
 Responsible for collecting and reviewing essential regulatory documents
 Responsible for reviewing ICFs from each site before and after IRB submission.
 Responsible to creating a visit reports and follow-up letter after each visit to notify the site about new and outstanding issues
 development of budgets and contracts and assist in development of Monitoring plan
 Generate and delivery of study payment to site and vendors
 Work with team and site personnel to ensure the study timeline is met
 Assist project manager and associate director for study budget, contracts and milestone
Clinical Trial Experience at Glenmark
Circulatory: Phase II, Randomized, Double blinded, Placebo control, Multi-Center trial to assess the Efficacy and Safety of Investigational Product in Subjects with Hypertension
Endocrine/Metabolic: Phase II, Randomized, Placebo control, Multi-Center trial to assess the Efficacy and Safety of Investigational Product in Subjects with Obesity
Vimta Labs, July 2003- Feb 2005
Clinical Research Associate
 Managing and monitoring Phase I, Dose escalation, Bioavailability and Bioequivalence, Pharmacokinetic Pharmacodyanamic and Food affect Bioavailability studies (Approx 100) on Healthy human subjects and patients in different therapeutic area.
Oncology:Advanced Solid Tumors Phase I (A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of study medication in patients with Advanced Solid Tumors)
Duties & Responsibilities
 Identification of potential Investigators in collaboration with the sponsor
 Performing Evaluation visits (SSV), initiations visits (SIV),Monitoring visits (SMV) and Close-out Visits (SCV)
 Performing Ethics Committee submissions.
 Source data verification
 Track and Report SAE/AE
 Generating & Resolving queries
 Monitoring Investigational Product Accountability
 Collection of Essential Documents
 Preparing Regulatory Compliance review packages
 Administrative set up of sites
 Organizing & participating Investigator Meetings
 Maintaining working knowledge of GCP, global SOP’s and applicable client SOP’s
 Archiving relevant documents as per procedures
 Preparing monitoring reports in timely manner
 Prepare grant documentation to ensure timely delivery of site payments and reconcile site financials at study completion.
 participate in providing protocol specific training
 Facilitating effective communication between Investigational sites & the project team through written, oral and electronic contacts
 Participate and assist in development of Monitoring Plans
 Development of budgets & Contract. Negotiation of budgets
 Work with appropriate areas to communicate supply and demand, assist with/lead ordering and tracking clinical and ancillary supplies.
 Reconcile site and study financials upon study completion.
CLINICAL TRIAL TRAINING
 CRA Foundation training certification sponsored by PPD
 Good Clinical Practice- GeneEd
 An Introduction to the Improved FDA Prescription Drug Labeling-FDA
 Therapeutic Trainings at PPD and Nectid
 ICH, GCP trainings at Investigator Meetings at Vienna and Italy.
TRAINING UNDER M. PHARM. CURRICULUM
 Trainee clinical pharmacist at a 550 beds hospital, Meenakshi Mission Hospital and Research Centre, India
 Mental Disorders: Open label, Randomized, Multicentric, Phase-III Clinical Trial at Torrent Research Centre in India of selective serotonin reuptake inhibitor (SSRI) to assess the safety and efficacy; new SSRI antidepressant drug carried out at Madurai Centre
LICENSES & CERTIFICATIONS
 Certified Pharmacist.
 Certified Advanced course on GCP by NIDA Clinical Trial Network
 Certified Basic course on GCP by NIDA Clinical Trial Network
 Certified on Protecting Human Research Participants by NIH office of Extramural Research
 Certified on Cancer Clinical Trial Basics by National Cancer Institute
 Certified for Clinical Research Training by NIH
 Certified for Pancreatic Cancer- GeneED
 Certification on Introduction to the Regulatory Process for Clinical Investigator- FDA
PROFESSIONAL AFFILIATIONS
 Member, Association of Clinical Research Professionals (ACRP)
 Student Member, Indian Pharmaceutical Association (IPA)
 Life Member, Indian Hospital Pharmacist Association (IHPA)
COMPUTER EXPERIENCE
 Windows XP professional, MS Word, Word Perfect, Excel, Power point, Internet
 Data acquisition and data analysis
 In windows operating systems and application software: ChemDraw, Reference Management Software (Endnote Plus), Sigma Stat.
 Scientific information retrieval using search engines like Science direct, Pub med, High wire, STN, Scirus, Scopus in Internet
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