Niketa Kamble
Jacksonville,FL
Summary
Dedicated Senior Project Manager with extensive experience in coordinating clinical trials, ensuring regulatory compliance, and maintaining data integrity. Proven track record in managing participant recruitment and training junior staff.
Overview
15
15
years of professional experience
Work History
Senior Project Manager, Rater
CNS Healthcare
Jacksonville, FL
12.2018 - Current
- Coordinated multi-site clinical trials, ensuring compliance with regulatory requirements and protocols.
- Participated in internal audits as well as inspections conducted by regulatory agencies, demonstrating compliance with industry standards.
- Managed participant recruitment processes, enhancing enrollment rates through targeted outreach strategies.
- Developed and maintained clinical trial databases ensuring data integrity and compliance.
- Monitored adverse events and reported findings to ensure participant safety throughout trials.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Developed and maintained study documentation, ensuring accuracy and consistency across all records.
- Trained and mentored junior staff on clinical trial procedures and best practices for data collection.
- Developed and implemented data collection processes to enhance accuracy and efficiency in study execution.
Research Assistant-EDC Data Entry Specialist
CNS Healthcare
Jacksonville, FL
12.2017 - 12.2018
- Responsible for data entry of study visits on various protocols, query resolution and ensuring all dataentry timelines are met support ongoing research projects and enhance team understanding of relevant studies.
- Skilled at working independently and collaboratively in a team environment.
- Organized and detail-oriented with a strong work ethic.
- Paid attention to detail while completing assignments.
- Assisted in data collection and analysis, ensuring accuracy and reliability of research outcomes.
- Developed and maintained comprehensive databases for tracking research progress and participant information.
- Collaborated with cross-functional teams to streamline project workflows and improve communication processes.
- Worked effectively in fast-paced environments.
Family Medicine Physician
Healthsprings
Mumbai, India
06.2015 - 09.2017
- Diagnosed and treated diverse patient conditions in outpatient settings.
- Developed comprehensive care plans to manage chronic diseases effectively.
- Collaborated with interdisciplinary teams to enhance patient outcomes.
- Implemented preventive health measures and education for patient populations.
- Developed strong relationships with patients and their families, fostering trust and ensuring open communication.
- Contributed to the overall success of the practice by collaborating effectively with colleagues and medical staff.
- Conducted regular preventive screenings to promote overall wellness among patients within the community.
- Maintained a high level of patient satisfaction, addressing concerns promptly and compassionately.
- Participated in ongoing professional development opportunities to continually enhance medical knowledge and skills.
Medical/Lead Surgical Assistant
Southside Dermatology
Jacksonville, FL
06.2013 - 06.2015
- Managed patient intake activities, including the updating of medical records and the confirmation of accurate information.
- Organized and coordinated patient appointments, ensuring smooth and efficient clinic workflow.
- Developed and enforced best practices for instrument preparation and sterilization, resulting in improved surgical workflow efficiency.
- Monitored and coordinated patient care during pre-operative and post-operative phases, emphasizing adherence to surgical standards in dermatologic and Mohs surgeries.
- Educated patients regarding post-surgical recovery strategies, fostering understanding and adherence to discharge instructions.
- Assisted surgeons during MOHS skin cancer surgery, excisions, skin biopsies ensuring sterile conditions and availability of necessary instruments.
Medical Assistant
Gulf Coast Dermatopathology Laboratory
Jacksonville, FL
01.2011 - 12.2012
- Assisted in patient intake, ensuring accurate collection of medical histories and insurance information.
- Managed appointment scheduling, optimizing patient flow and reducing wait times.
- Administered medications and injections under physician supervision, adhering to safety protocols.
- Conducted preliminary assessments, documenting vital signs and assisting with dermatological procedures.
Education
ECFMG Certification - Medicine And Surgery
ACGME
Chicago, IL04.2009
MBBS(Bachelor of Medicine And Bachelor of Surgery) - Medical School
Topiwala National Medical College
Mumbai, India04.2004
Rotatory Internships - Medicine And Surgery
BYL Nair Charitable Hospital
Mumbai, India04.2004
Skills
- Project planning
- Scope management
- Client relationship management
- Project scheduling
Languages
English
Native or Bilingual
Marathi
Native or Bilingual
Hindi
Native or Bilingual
Spanish
Limited Working
Japanese
Limited Working
Timeline
Senior Project Manager, Rater
CNS Healthcare
12.2018 - Current
Research Assistant-EDC Data Entry Specialist
CNS Healthcare
12.2017 - 12.2018
Family Medicine Physician
Healthsprings
06.2015 - 09.2017
Medical/Lead Surgical Assistant
Southside Dermatology
06.2013 - 06.2015
Medical Assistant
Gulf Coast Dermatopathology Laboratory
01.2011 - 12.2012
ECFMG Certification - Medicine And Surgery
ACGME
MBBS(Bachelor of Medicine And Bachelor of Surgery) - Medical School
Topiwala National Medical College
Rotatory Internships - Medicine And Surgery
BYL Nair Charitable Hospital