Clinical Research Coordinator with Oncology Experience

Hima Gottipati

Summary

Hima is a dedicated professional with 2 years of experience as a Clinical Research along with working with oncology. In her previous role, she was responsible for identifying, selecting, initiating and close out appropriate investigational sites for clinical studies. She has excellent communication skills. She is available to join immediately once offered. Education

● Applied Science in Dental Hygiene, Oakland College, Waterford, US – August 2006 – April 2010

● Bachelor of Dental Surgery, Saveetha Dental College, Chennai - December 1996 – February 2001 Saveetha Hospitals.

Jan2000-feb 2002.

● Identified, Initiated, Monitored and close out the sites.

● Have real experience working with oral cancer patients in terminal stages.

● Selection of patients for procedures.

● Reviewed Patient Medical Charts, verify informed consents and monitor patient safety by noting Adverse events, Serious Adverse events, concomitant Medications in accordance with the protocol.

● Have experience working with Real stage4 cancer Patients. concentrix RESEARCH.

Jan 2020- dec 2022

● Develop and collaborate relationship with sites In rural areas, community centres in rural areas. Identified, initiated, monitored and close out investigational sites in accordance with standard operating procedures (SOPs) and FDA guidelines.

• Verified that the investigator and all research staff has adequate qualifications and resources and all facilities remain adequate throughout the trial period to safely and properly conduct the trial.

• Assured the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedures through the review of CRFs.

• Sourced documents and medical records and regulatory documents.

• Coordinated timely shipment of clinical supplies and study drugs to sites and ensure drug accountability in accordance with applicable regulatory requirements.

• Reviewed patient medical charts, verify informed consent forms (ICFs) and monitor patient safety by ensuring that adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol.

• Prepared visit reports and contribute information for status reports for sponsors.

• Developed and maintain solid collaborative working relationships with investigators, site staff and sponsor. DFW CLINICAL RESEARCH ASSOCIATES.

JAN2023- Present

Presently working as a clinical research coordinator on the following studies

● KP1077. D01A-Phase 2, placebo- controlled, Double- Blind, Randomized Withdrawal Study to Determine the safety and Efficacy of Oral SDX in Patients with Idiopathic Hypersomnia.

● KPL-404-C211 A Phase 2, Multicenter, Randomized, Double- Blind, Placebo- Controlled study to Assess the safety, Pharmacokinetics, and Efficacy of KPL-404 In Subjects with Moderate to severe, Active Rheumatoid Arthritis with inadequate Response or intolerance to at least one biologic Disease modifying Anti- Rheumatic drug or a Janus kinase inhibitor.

● AR1001-ADP3-US01- A Phase3 Double- Blind, Randomized, Placebo- Controlled, Multi center Trial to Evaluate The Efficacy and safety of AR1001 over 52 weeks in participants with Early Alzheimers disease.

● LG-GDCL010- A Randomized, Multi- regional, Double- blind, Double- Dummy parallel group, placebo and Allopurinol- controlled phase3 study to assess the Efficacy and safety of Tigulixostat in Gout patients with Hyperuricemia.

● IM011246 A Phase 3, Randomized, Double- blind, Placebo- controlled study to evaluate the efficacy and safety of Deucravacitinib in participants with Active Systemic lupus erythematosus{ SLE} {POETYK SLE-1} Protocol Amendment 01.

● ProtocolM23-699 A Phase3 program to evaluate the safety and efficacy of Upadacitinib in subjects with Moderately to severely Active systemic lupus Erythematosus.

• M23-698 A Phase 3 Randomized, Placebo- controlled, Double- Blind Study to Evaluate Efficacy and safety of an investigational drug in Adult and Adolescent subjects with Moderate to severe Hidradenitis suppurativa who have failed Anti- TNF Therapy. Verified that the investigator and all research staff has adequate qualifications and resources and all facilities remain adequate throughout the trial period to safely and properly conduct the trial.

• Assured the integrity of clinical data with respect to accuracy, accountability, documentation and methods or procedures through the review of CRFs.

• Sourced documents and medical records and regulatory documents.

• Coordinated timely shipment of clinical supplies and study drugs to sites and ensure drug accountability in accordance with applicable regulatory requirements.

• Reviewed patient medical charts, verify informed consent forms (ICFs) and monitor patient safety by ensuring that adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol.

• Prepared visit reports and contribute information for status reports for sponsors.

• Developed and maintain solid collaborative working relationships with investigators, site staff and sponsor. HIMA GOTTIPATI

06/17/2024.

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