JAGADISH

CLINICAL RESEARCH ASSOCIATE

ad0t0j@r.postjobfree.com 203-***-**** NEW JERSEY,USA

Summary

Highly experienced and results-driven Clinical Research Associate (CRA) and Clinical pharmacist with 7 years of expertise in managing and monitoring clinical trials. Proven track record of ensuring the successful execution of clinical research projects while maintaining compliance with regulatory guidelines and protocols.

Strong knowledge of GCP guidelines and industry best practices, with a keen eye for detail and data integrity.

Demonstrated ability to build strong relationships with site staff and investigators, ensuring efficient study conduct and participant safety.

Regulatory compliance: In-depth knowledge of regulatory requirements, including ICH-GCP guidelines, FDA regulations, and local regulatory authorities.

Strong site management: Proven ability to establish and maintain effective relationships with site personnel, investigators, and study coordinators, ensuring adherence to protocols and timely data collection.

Meticulous attention to detail in reviewing study documents, source data, and case report forms (CRFs) to maintain data accuracy and compliance.

Efficient problem-solving: Proactive in identifying and resolving data discrepancies, protocol deviations, and adverse events (AEs), ensuring participant safety and trial integrity.

Proficient in monitoring activities: Extensive experience in conducting site initiation, routine monitoring, and closeout visits, ensuring site readiness, protocol compliance, and accurate data collection.

Technical expertise: Proficient in utilizing electronic data capture (EDC) systems, clinical trial software, and data management tools to streamline monitoring and data collection processes.

Exceptional communication skills: Strong interpersonal skills facilitating effective collaboration with cross-functional teams, site personnel, and study participants.

Trial Documentation: Maintaining and organizing trial documentation, including the Trial Master File (TMF), essential documents, and correspondence, to ensure completeness, accuracy, and accessibility. Safety Reporting: Monitoring and reporting adverse events (AEs) and serious adverse events (SAEs) in compliance with regulatory requirements and sponsor-specific guidelines. Ensuring appropriate documentation and timely reporting to the relevant stakeholders.

Protocol Adherence: Verifying that all study procedures are conducted in accordance with the study protocol, including investigational product handling, data collection methods, and participant visit schedules.

Documentation of Site Visits: Documenting site visit findings, observations, and any deviations from the protocol or regulatory requirements in monitoring reports and visit documentation.

Training and Education: Staying updated with relevant guidelines, regulations, and industry best practices through ongoing training and professional development activities. Sharing knowledge and expertise with site personnel, as needed.

Study Progress Tracking: Monitoring study progress, timelines, and milestones to ensure adherence to project timelines and deliverables.

Strong interpersonal skills facilitating effective collaboration with cross-functional teams, site personnel, and study participants.

Skills

SAS, EHR Go

BI/Visualization Tools

(Tableau server 8.x/9. x./10., Tableau Reader 8.x, SSRS, Tableau Desktop 7.x/8.x/ 9.x, Micro strategy, Tableau Public 9.2)

Programming

(SQL, PL/SQL, MySQL)

Therapeutic areas

•Anti-diabetic

•Cardiovascular

•Oncology

•Antivirals

•Antihypertensive

•Anti-hyperlipidemic

Databases

(Teradata, DB2, Oracle SQL Server 2012/14/16/17, MS Access. Medidata Rave, oracle &MedDRA)

Professional Experience

Clinical Research Associate, Modavar pharmaceuticals

Conducted site initiation, routine monitoring, and closeout visits at multiple investigative sites, ensuring compliance with study protocols, GCP guidelines, and applicable regulatory requirements.

Verified the accuracy and completeness of source data, case report forms (CRFs), and other trial-related documentation.

Developed and maintained strong relationships with site staff, investigators, and study coordinators, providing guidance and support throughout the study.

Assisted in site selection, feasibility assessments, and contract negotiation processes.

Conducted site training on protocol-specific procedures, data collection, and regulatory obligations.

Oversaw participant recruitment and enrollment, ensuring adherence to inclusion/exclusion criteria and ethical considerations.

Proactively identified and resolved data discrepancies, protocol deviations, and adverse events (AEs).

Performed remote and on-site data monitoring activities using electronic data capture (EDC) systems.

Contributed to the development and review of study-specific documents, including protocols, informed consent forms, and study manuals.

Participated in the preparation and conduct of investigator meetings and sponsor audits.

Clinical Research Associate, vimta labs

Site Monitoring: Conducting routine site visits activities to ensure protocol compliance, participant safety, and data accuracy. Includes reviewing, case report forms (CRFs), protocols.

Reviewing study data. Resolving data queries by communicating with site personnel. investigators, and study coordinators to ensure timely resolution and accurate data reporting.

Monitoring participant enrollment, ensuring adherence to inclusion/exclusion criteria, and verifying proper informed consent procedures according to regulatory and ethical guidelines.

11/2021 – present Maryland, USA

06/2019 – 07/2021

Hyderabad, India

Ensuring that the trial is conducted in accordance with relevant regulatory guidelines, including Good Clinical Practice (GCP). Verifying that all necessary regulatory documents, such as informed consent forms and ethics committee approvals, are in place.

Maintaining and organizing trial documentation, including the Trial Master File (TMF), essential documents.

Monitoring and reporting adverse events (AEs) and serious adverse events (SAEs) in compliance with regulatory requirements and sponsor-specific guidelines. Ensuring appropriate documentation and timely reporting to relevant stakeholders.

preparing study progress, timelines, and milestones to ensure adherence to project timelines and deliverables.

Clinical pharmacist, VHS Hospitals

•Medication Review: Conduct comprehensive medication reviews for patients, including evaluating medication appropriateness, assessing drug interactions, and identifying potential adverse effects.

•Patient Counseling: Provide medication counseling to patients, including proper medication use, potential side effects, and adherence strategies. Answer patient questions and address concerns regarding their medications.

•Clinical Rounds: Participate in interprofessional clinical rounds with physicians, nurses, and other healthcare professionals to provide expertise on medication-related issues, therapeutic interventions, and medication reconciliation.

•pharmacotherapy Monitoring: Monitor patients' response to medication therapy, review laboratory values, and adjust drug regimens accordingly. Collaborate with prescribers to optimize therapeutic outcomes and ensure appropriate medication utilization.

•Education and Training: Provide education and training to healthcare professionals, including physicians, nurses, and pharmacy students. Conduct in-service training sessions on medication-related topics and participate in continuing education activities.

•Documentation and Reporting: Maintain accurate and complete patient medication.

07/2015 – 04/2019

Chennai, India

Education

Master of Healthcare Informatics, Sacred Heart University Connecticut, USA

Doctor of Pharmacy, Dr. MGR University Chennai, India

Contact this candidate