Summary
Overview
Work History
Education
Skills
Certification
PRESENTATION
PUBLICATIONS
CONFERENCES
ONSITE CLINICAL RESEARCH EXPERIENCE
PROJECTS
Timeline
Generic
Jestin George Joseph

Jestin George Joseph

Tempe,AZ

Summary

Highly qualified with 13 years of medical research experience. Experienced in both medical practice and clinical research environments performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. Experienced in multiple study areas, including diabetes, hypertension, gastrointestinal, cardiovascular, renal, neurology and psychiatry. Recognized for initiative, organization, time and task management, sound problem solving skills and flexibility.

Overview

11
11
years of professional experience
1
1
Certification
6
6
years of post-secondary education

Work History

TRAINING AND DEVELOPMENT SPECIALIST

CCT Research, an Avacare buisness
12.2021 - Current
  • Onboard new hires at the site level and aid in their training of policies and procedures
    during their first 4 weeks of employment.
  • Prepare sites for FDA and Sponsor Audit
  • Monitor and assess the quality of the data collected
    Identify and assess gaps in the training program, create solutions, and anticipate future
    training needs
  • Create, oversee, and implement a communication plan for company training programs to
    all employees and management teams to drive understanding and participation
  • Assign CITI trainings and manage all regulatory documents
  • Actively pursue the latest developments within the industry and competitors
  • In addition to virtual instructor-led training, travel to CCT site locations; 50% travel
  • Created 13 courses for CCT fast track academy.
  • Provides scientific input to Study Manager (SM) for data management activities
  • Proactively articulate the status of training programs, interactions and results
  • Comply with CCT, Clinic, and Sponsor policies, standard operating procedures (SOPs) and
    guidelines
  • Provides scientific assessment for Operational Reviews
    Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Screened patient records, databases, and physician referrals to identify prospective
    candidates for research studies.

SENIOR CLINICAL RESEARCH ASSOCIATE

Yanuvia, LLC
02.2021 - 12.2022
  • Ensure that all trainings are complete for all study personnel and documentation maintained in the regulatory binder
  • Ensure all necessary forms are submitted to sponsors and the IRB in timely manner.
  • Submit initial applications for study approval to the IRB. Submit continuing review reports, closeout reports, and other materials to the IRB for approval and process accordingly
  • Complete and send out NDAs, Contracts and Site Information Forms and Clinical point of contact for scientific issues/questions
  • Write SOPs and Manage all 70 sites and 3 studies
  • Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
  • Reconciles and review all protocol deviation classifications in SMART
  • Coordinate and store protocol files, protocol submission documents including correspondence from sponsor and study team.
  • Prepares scientific slides, attends and presents protocol information at Investigator Meeting
  • Experience preparing source documents, reviewing and conducting Informed Consent process with subjects, EDC entry and query resolution, and completing all study specific documents within the specified timeline.
  • Communicate with study staff to ensure the maintenance and accuracy of the Delegation of Authorities log and other important logs

LEAD CLINICAL RESEARCH COORDINATOR

Clinical Research of Central Florida
06.2019 - 02.2021
  • Involved in patient screening and enrollment for clinical studies
  • Coordinating the clinical trials in compliance with all FDA protocols and specifications
  • Maintain regulatory-related internal tracking databases and filing systems.
  • Meets with pharmaceutical/sponsor monitors.
  • Preparing and maintaining clinical trial source documents
  • Conducting study visits, including vital signs, ECG, blood draw, and processing labs
  • Completing and ensuring the quality of case report forms
  • Coordinates planning of lab, bio specimens and imaging specifications
  • Maintaining and dispensing drugs
  • Preparing for site monitoring visits and site selection visits
  • Provides clinical specifications to SM to support interactions with external vendors
  • Maintaining documentation regarding all aspects of the study

PHARMACY TECHNICIAN

Walmart
08.2018 - 05.2019
  • Completes work assignments and priorities.
  • Comply with Medicare and Medicaid policies and procedures.
  • Comply with company policies, procedures, and standards of ethics and integrity.
  • Ensure fulfillment of pharmacy prescriptions in a Retail Pharmacy.
  • Enter prescriptions data into pharmacy software.
  • Maintain quality, accuracy, and integrity of inventory.
  • Monitor and resolve problems in the prescription fulfillment process.

CLINICAL RESEARCH COORDINATOR

LNSCNR - Nitte University
09.2016 - 06.2018
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Discuss study with patients and verify inform consent documentation Provide patient with written communication of their participation
  • Meet with the patient for each visit and complete study source documentation worksheets.
  • Schedule the patient for all study visits and procedures within guidelines/timeframes specified in the protocol.
  • Review CRFs against the patient's medical record for completeness accuracy.
  • Screen, interview, assess, and evaluate participant eligibility for various studies as directed by the study protocol.
  • Administer psychometric/psychological rating scales and other scales protocol as assigned.
  • Conducts interviews and administers psychosocial questionnaires, bl pressure and pulse, physical fitness, and collects of other research da.

CLINICAL RESEARCH COORDINATOR

NUCARE- Nitte University
06.2012 - 09.2016
  • Experience with handling lab animals (mice), animal husbandry, maintaining colonies and procurement of tissues.
  • Familiarity with in vivo drug administrations.
  • Familiarity in DNA/RNA extractions, gel electrophoresis, RT-PCR.
  • Familiarity with flow cytometry and Immune cell phenotyping.
  • Familiarity working with animals in a Cancer Biology/Tumor biology, or Immunology lab.
  • Familiarity with in vitro cell culture of primary and/or tumor cell lines.
  • Familiarity with Immunofluorescence and fluorescent microscopy.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Collected data and followed research protocols, operations manuals case report form requirements.



Education

Master of Health Administration -

Capella University
Minneapolis, MN
2020 - 2021

Master of Pharmacy - Pharmacy Practice

NITTE University
Karnataka, India
2016 - 2018

Bachelor of Pharmacy - Pharmaceutical

NITTE University
Karnataka, India
2012 - 2016

Skills

  • Leadership & Patient Counseling
  • Administer C-SSRS
  • Dispense Investigational Product
  • Good Clinical Practices
  • Batch record analysis
  • Perform ECG
  • Lab Sample Collection and Processing
  • IWRS System
  • Informed consent process
  • Lab Equipment Calibration
  • Excel, PowerPoint, Sharepoint
  • CITI Admin access

Certification

  • Pharmacist Intern - Florida Board of Pharmacy - License NO: PSI 40418.
  • Registered Pharmacist - India - License No: 56653 - Issued 7 Sep 2016
  • Basic Life Support (BLS) - CPR and AED
  • GCP Certified - CITI Program, NIDA Clinical Trial Network & TransCelerate
  • IATA Certified
  • C-SSRS Certified - RFMH





PRESENTATION

  • Presented a paper entitled 'ASSESSMENT OF METABOLIC RISK FACTORS IN PATIENTS UNDERGOING ANTIPSYCHOTIC DRUG THERAPY' in Student Research Convention 'ANVESHAN'

PUBLICATIONS

Assessment of metabolic risk factors in patients undergoing antipsychotic drug therapy: A Pharmacist-led study.

Joseph, J. G., Prabhu, S., Chand, S., Roy, D. A., Nandakumar, U. P., George, S. M., & Joel, J. J. (2021). Assessment of metabolic risk factors in patients undergoing antipsychotic drug therapy: a Pharmacist-led study. Le Pharmacien Hospitalier et Clinicien.

CONFERENCES

  • Attended "FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Virtual Conference" organized by SOCRA. CE hours: 11.25
  • Attended ICMR sponsored National Conference on “HEALTH ECONOMICS AND QUALITY USE OF MEDICINES” organized by the Department of Pharmacy Practice, N.G.S.M.I.P.S, Mangaluru, on 1st and 2nd December 2017.
  • Attended ISPOR sponsored ONE DAY NATIONAL SEMINAR on “PHARMACOECONOMICS AND PATIENT SAFETY” organized by the Department of Pharmacy Practice held on 11th January 2017.
  • Attended ICMR sponsored one day symposium on “ANIMALS IN BIOMEDICAL RESEARCH: THE PRESPECTIVES” organized by N.G.S.M.I.P.S on 22nd Jan 2016

ONSITE CLINICAL RESEARCH EXPERIENCE

  • Protocol mRNA-1345-P301: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years of Age
  • Protocol mRNA-1345-P302: A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered with a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine in Adults ≥ 50 Years of Age
  • Protocol mRNA-1020-P101: Phase 1/2, randomized, observer-blind, dose-ranging study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1020 and mRNA-1030 candidate seasonal influenza vaccines in healthy adults.
  • Protocol SM04690-OA-07: A 48-Week, Placebo-Controlled, Single Blind Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects with Osteoarthritis of the Knee
  • Protocol SM-04690-OA-10: A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.
  • Protocol SM-04690-OA-11: A Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Utilizing Patient-Reported and Radiographic Outcomes to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects.
  • Protocol R10933-10987-COV-2067: ASSESSING THE SAFETY, TOLERABILITY, AND EFFICACY OF ANTI-SPIKE (S) SARS-COV-2 MONOCLONAL ANTIBODIES FOR THE TREATMENT OF AMBULATORY PATIENTS WITH COVID-19.
  • Protocol R10933-10987-COV-2067: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2.
  • Protocol R10933-10987-COV-20145: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
  • Protocol NN14138-4477: A 78-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with non-insulin anti-diabetic treatment, in insulin naïve subjects with type 2 diabetes.
  • Protocol NYX-2925-2008: A Randomized, Double-Blind, Placebo‑Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy.
  • Protocol C4491011: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of Vupanorsen (PF-07285557) in Statin-Treated Participants with Dyslipidemia.
  • Protocol NN1436-4481: ONWARDS 5 - Effectiveness and safety of once weekly insulin icodec used with DoseGuide versus once daily basal insulin analogues in an insulin naïve type 2 diabetes population in a clinical practice setting.
  • Protocol D7551C00001: A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants with Proteinuric Chronic Kidney Disease.
  • Protocol ABP-20001: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache.
  • Protocol STS101-003: An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine.
  • Protocol 2118001: Nasal Swab Collection in Patients Symptomatic of or Confirmed Positive for COVID-19, Influenza A, or Influenza B.

PROJECTS

  • Assessment of Metabolic risk factors in patients undergoing anti-psychotic drug therapy
  • Bioassay of acetylcholine in isolated chicken ileum
  • Study on Neuroleptic Induced Movement Disorders in Psychiatric Inpatient
  • Statin Induced Diabetes
  • Review on Floating Drug delivery System of Anti-Hypertensive Drugs

Timeline

TRAINING AND DEVELOPMENT SPECIALIST

CCT Research, an Avacare buisness
12.2021 - Current

SENIOR CLINICAL RESEARCH ASSOCIATE

Yanuvia, LLC
02.2021 - 12.2022

Master of Health Administration -

Capella University
2020 - 2021

LEAD CLINICAL RESEARCH COORDINATOR

Clinical Research of Central Florida
06.2019 - 02.2021

PHARMACY TECHNICIAN

Walmart
08.2018 - 05.2019

CLINICAL RESEARCH COORDINATOR

LNSCNR - Nitte University
09.2016 - 06.2018

Master of Pharmacy - Pharmacy Practice

NITTE University
2016 - 2018

Bachelor of Pharmacy - Pharmaceutical

NITTE University
2012 - 2016

CLINICAL RESEARCH COORDINATOR

NUCARE- Nitte University
06.2012 - 09.2016
  • Pharmacist Intern - Florida Board of Pharmacy - License NO: PSI 40418.
  • Registered Pharmacist - India - License No: 56653 - Issued 7 Sep 2016
  • Basic Life Support (BLS) - CPR and AED
  • GCP Certified - CITI Program, NIDA Clinical Trial Network & TransCelerate
  • IATA Certified
  • C-SSRS Certified - RFMH





Jestin George Joseph