MANASA GANTI
Irving,TX
Summary
Proven Clinical Research Coordinator with extensive experience at Southwest Family Medicine, adept in regulatory knowledge and clinical trial coordination. Demonstrated success in enhancing patient recruitment by 30% and ensuring protocol adherence, showcasing strong analytical skills and interpersonal abilities. Excelled in maintaining compliance with FDA, ICH, and GCP guidelines, contributing to groundbreaking research in multiple therapeutic areas.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
Southwest Family Medicine
Dallas, Texas
09.2024 - Current
- Facilitated pre-study assessments, site qualification and initiation, monitoring visits, and study close-out activities
- Managed participant recruitment, (pre)screening, and enrollment
- Educated participants and their family members on the details of the research study
- Ensured compliance with the protocol, SOPs, GCP, and other applicable regulations
- Coordinated protocol-related research procedures, study visits, data collection and reporting, participant care, and follow-up
- Worked with site clinical staff to ensure the completion of study tasks
- Collected, processed, and shipped study laboratory specimens
- Created and maintained study source documents
- Managed drug accountability and reconciliation
- Handled IRB/Sponsor/CRO communications, preparing and submitting regulatory documents for IRB review and approvals
- Managed, marketed, and facilitated all aspects of the Research Center
- Ensured full compliance with HIPAA regulations, maintaining confidentiality and security of patient information during clinical trials and throughout the research process
- Maintained strict adherence to HIPAA regulations, conducting periodic audits to ensure confidentiality and compliance with patient data security protocols
- Experience in Therapeutic Areas: Phase III (Asthma Study), Phase III (Type2 Diabetes), Phase II (heart disease and high Lpa), Phase III (Heart Attack / MI), Ophthalmology (Observational Study), Regeneron (Asthma Study)
Clinical Research Coordinator
Krishna Institute of Medical Sciences
Hyderabad, India
09.2017 - 11.2021
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols, regulations and guidelines and internal standard operating procedures
- Ensured strict adherence to research protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines throughout all phases of clinical trials
- Collected data and followed research protocols, operations manuals, and case report form requirements, and obtaining written informed consent as appropriate
- Maintained compliance with protocols covering patient care and clinical trial operations
- Utilized patient records, databases, and physician referrals to identify and enroll suitable participants for clinical trials
- Ensured that the regulatory documents and administrative files for each protocol are all up-to-date and adhered to the sponsor’s requirements
- The screening of medical records, databases, and referrals to the doctor to get potential research participants for the research studies
- The trials of such disorders like obesity and Gynecology are taken care of by coordinated clinical studies
- Digital data collection, input, checking and maintenance of the initial data with the help of electronic data capture (EDC) systems
- Orientational and compilation study standard documents were my workload - including informed consent forms, case report forms (CRFs) and regulatory submissions
- Worked openly with all the cross-functional departments, such as investigators, study coordinators, data managers, and clinical site staff
- The primary purpose is to enable the study meetings on site, initiate visits, and train the team to guarantee congruence in study and goal objectives
- Assisted in the conduct of the final study termination activities such as the completion of data collection, plan the reconciliation, and safekeeping of records
- Have been consistent on continuing professional development hence keeping myself abreast of industry trends, best practices, and ongoing regulatory
- Experience in Therapeutic Areas: Phase II (Endocrinology), Phase III (Gynecology), Phase II (General Medicine)
Clinical Research Coordinator Intern
Gleneagles Aware Global Hospitals
Hyderabad, India
03.2017 - 08.2017
- Involved in collecting and submitting regulatory files, such as the Institutional Review Board application (IRB), informed consent forms, and the study protocol
- Actively recruited study participants through the design of informative flyers, posters, and social media content to lift the curtain on active clinical trials
- Consistently reached out to the volunteers of the study visits, comprising of scheduling participant appointments, making transportation arrangements, and supplying the research materials
- Enabled the tracking and reporting of adverse events, instances of protocol deviations, and other study-relevant problems to the principal investigator and other investigators
- Attended team meetings as well as training sessions to grasp the concept behind ethics in clinical trials as per GCP guidelines, and how it is done
- Working under all the experienced Clinical Research Coordinators allowed me to see how the studies are carried out, i.e
- Patient communication, administration and supervision processes, and regulatory adherence
- Acquired a high skill level in working with electronic data capture (EDC) systems and data input, query procedure and report generating systems
- The main aspects of my role were performing work within the context of each department, contributing to projects and initiatives providing important advice and help that entails all the team's clinical work
- Partaking of the processes of the Clinical Research Coordinators under the scope of a mentor was my endeavor to see how studies are done, patients are treated, and regulations are complied with in a real-world setting
- Integrated into the procedure planning and studied some relevant subjects, like blood draws, vital sign measurements, and interviews with patients to implement protocols
Education
Master of Science - Health Informatics
University of North Texas
Denton, Texas12-2023
Doctor of Pharmacy - Pharmaceutical Sciences
Sree Dattha Institute of Pharmacy
Hyderabad, India07-2020
Skills
- Regulatory Knowledge
- Clinical Trial Coordination
- Interpersonal skills
- FDA
- Protocol Adherence
- Analytical Skills
- ICH
- Informed Consent
- Problem solving
- GCP
- Data Collection & Management
- Ability to work independently
- EDC
- Patient Recruitment
- Organizational skills
- IRB
- IRB Submission
- Meeting deadlines
- HIPPA
- Monitoring & Reporting Adverse Events
- Self-motivated
- SOP
- Study Protocol Development
- Written & communication skills
- Medidata / Zelta
- CTMS
- TMF
- E Sourcing
- EMR
- Case Report Forms
- IATA
Certification
- Certified Clinical Research Coordinator, Krishna Institute of Medical Sciences
- Certification in Good Clinical Practice, NIDA Clinical Trials Network.
- Certification in ICH GCP E6 (R2), The Global Health Network
- Certification in Introduction to Clinical Research, The Global Health Network.
- Certification in GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), CITI.
- Certification in GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus), CITI.
- Certification in IATA (Dangerous Goods Training), Mayo Clinics.
- Certification in Advanced Clinical Trial Assistant (ACTAC), CCRPS.
- Certification in Clinical Research Associate (CRA), CITI.
Timeline
Clinical Research Coordinator II
Southwest Family Medicine
09.2024 - Current
Clinical Research Coordinator
Krishna Institute of Medical Sciences
09.2017 - 11.2021
Clinical Research Coordinator Intern
Gleneagles Aware Global Hospitals
03.2017 - 08.2017
Master of Science - Health Informatics
University of North Texas
Doctor of Pharmacy - Pharmaceutical Sciences
Sree Dattha Institute of Pharmacy
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