Shivam J

Shivam J Email and Phone Number

Experienced Clinical Research Associate with a strong background in managing multiple clinical studies. @ Machaon Diagnostics
Emeryville, CA, US
Shivam J's Location
Emeryville, California, United States, United States
Shivam J's Contact Details

Shivam J work email

Shivam J personal email

About Shivam J

As a highly skilled Clinical Research Associate, I bring a wealth of experience in managing clinical studies from start to finish. I have a proven track record of successfully coordinating with cross-functional teams, overseeing multiple studies simultaneously, and ensuring that all study requirements are met. My expertise includes developing and managing electronic Trial Master Files, recruiting study participants, and maintaining Source data documents per HIPAA and Good Clinical Practice guidelines. I am committed to ensuring ethical and accurate research practices and have a comprehensive understanding of study protocols and regulations. I am passionate about clinical research and am eager to continue developing my skills and contributing to the success of clinical studies. My strong communication and interpersonal skills, attention to detail, and ability to manage multiple projects make me a valuable asset to any clinical research team.FDA Regulations: 45 CFR 46, 21 CFR 3,4, 11, 50, 56,58,312, 340

Shivam J's Current Company Details
Machaon Diagnostics

Machaon Diagnostics

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Experienced Clinical Research Associate with a strong background in managing multiple clinical studies.
Emeryville, CA, US
Employees:
45
Shivam J Work Experience Details
  • Machaon Diagnostics
    Machaon Diagnostics
    Emeryville, Ca, Us
  • Machaon Diagnostics
    Clinical Research Associate
    Machaon Diagnostics Mar 2022 - Present
    Berkeley, California, Us
    - As a Clinical Research Associate, I have gained extensive experience in managing and coordinating multiple clinical studies. I have a proven track record of ensuring ethical and accurate research practices through strict adherence to protocols and regulations.-I have been responsible for developing and managing electronic Trial Master Files (TMF) and binders for clinical studies while maintaining a clinical project directory. This has resulted in more efficient research project data collection and has reduced manual labor by 5%. I have also entered data from over 100 studies into electronic data capture systems (EDC) and databases (COPIA) while maintaining a less than 1% error rate.-In addition to my experience in managing and coordinating clinical studies, I have also assisted with site management, site initiation, and selection visits. I have collaborated with investigators and site personnel to ensure that all study requirements are met, and have provided guidance and support throughout the study process.-Conducted site training on study procedures and protocols during site initiation visits-I have also monitored 10+ clinical studies to ensure adherence to study protocol , SOPs, ICH-GCP principles, and applicable regulations.- I have coordinated multiple projects and prepared study-specific documents such as clinical study protocols, SPA, IRB Protocols, and data reports.-Coordinated with the sponsor, assay personnel, principal investigator (PI), and cross-functional teams to oversee 5-7 clinical studies from sample receipt to testing
  • Northeastern University
    Rso Proctor
    Northeastern University Dec 2019 - Apr 2021
    Boston, Ma, Us
  • Northeastern University
    Office Associate
    Northeastern University Aug 2019 - Dec 2019
    Boston, Ma, Us

Shivam J Skills

Leadership Clinical Trials International Regulations Electronic Data Capture Clinical Research Communication Regulatory Affairs Healthcare Team Leadership Clinical Trial Management System Good Clinical Practice Ich Pharmacovigilance Microsoft Office Project Coordination Drug Development Leadership Development Clinical Development Time Management Regulatory Submissions Team Motivation Teamwork Documentation Project Management Research Pharmaceutical Industry Problem Solving Iso Standards Trial Master File

Shivam J Education Details

  • Northeastern University
    Northeastern University
    Clinical Research
  • Duke University
    Duke University
    Regulatory Affairs Program
  • Gujarat Technological University (Gtu)
    Gujarat Technological University (Gtu)
    Pharmacy

Frequently Asked Questions about Shivam J

What company does Shivam J work for?

Shivam J works for Machaon Diagnostics

What is Shivam J's role at the current company?

Shivam J's current role is Experienced Clinical Research Associate with a strong background in managing multiple clinical studies..

What is Shivam J's email address?

Shivam J's email address is js****@****ail.com

What schools did Shivam J attend?

Shivam J attended Northeastern University, Duke University, Gujarat Technological University (Gtu).

What skills is Shivam J known for?

Shivam J has skills like Leadership, Clinical Trials, International Regulations, Electronic Data Capture, Clinical Research, Communication, Regulatory Affairs, Healthcare, Team Leadership, Clinical Trial Management System, Good Clinical Practice, Ich.

Who are Shivam J's colleagues?

Shivam J's colleagues are Daphne Bocaling, Katherine Saucier, Angela Marie Sacramento, Yamini Bynagari, Zaya Shiilegdamba, Connie Ng, Nathan Harvey.

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