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Priyanka K. is an accomplished Clinical Research Professional and licensed medical doctor based out of the Austin, Texas Metropolitan Area. Currently serving as a Clinical Research Associate in Oncology at AbbVie, Priyanka brings forward a robust expertise in clinical education, patient management, along with a strong acumen in executing intricate healthcare plans within regulated facilities. She's also a devoted member of professional organizations like the American College of Physicians and the Association of Clinical Research Professionals.
Priyanka's professional journey started in India, where she practiced as an Attending Physician with Lybrate from 2020. However, her interest in Clinical Research propelled her to acquire comprehensive training from VIARES in Vienna. Here, she delved into various aspects like the Medicines Development Process, Good Clinical Practice (GCP), regulatory environment, and associated areas. Her contributions in these fields equipped her to perform her current role at AbbVie aptly since 2023, where she manages the progress of assigned studies, conducts regular site visits, and oversees the quality and integrity of study site practices.
Priyanka possesses a Bachelor of Medicine and Surgery (MBBS) degree from the Osmania Medical College, Hyderabad, India completed between 2013-2019. Interestingly, she also holds an Associate's degree in Kuchipudi dance from Potti Sri Ramulu Telugu University, highlighting her diverse interests and abilities. Through her professional zeal, she continuously looks for initiatives that bring better learning opportunities and more defined competencies and standards to her clinical research role.
More about this expert
- Full name
- Priyanka K
- Location
- Austin, Texas Metropolitan Area
- Title
- Clinical Research Associate-Onchology
- Company
- AbbVie (since 2023)
- Industry
- Pharmaceutical Manufacturing
- LinkedIn profile
- https://www.linkedin.com/in/priyanka-k-210167123/
- LinkedIn Connections
- 3835
- Summary
- -Self directed and driven Clinical research professional and a medical doctor (licensed physician in India) with comprehensive accomplishments leading critical care, basic, cardiac and advanced life support, patient management, clinical education and cross functional teams to achieve goals. -An innovative thinker with strong supervisory, training, accreditation and continuum of care acumen. -Demonstrated success in developing and executing plans in complex, regulated healthcare facilities. -Recognized for implementing impactful care plans through analysis of the details to understand the patient needs, emerging trends and relationships. -Highly organized, creative problem solver who excels at guiding teams through challenging times. -Expertise in managing large case loads, communication and advising nursing staff and care givers. -Trained in different aspects of clinical research like: 1. ICH GCP E6 R(2) 2. FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46 3. Data Management 4. Informed Consent Process 5. Clinical Trial Operations from feasibility through close-out. 6. GDP following ALCOA-C principles 7. Identification and reporting of AEs and SAEs 8. Quality Assurance, Monitoring and Query Resolution 9. Comprehension and Execution of Clinical Trial Protocols 10. Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Source documents, and other Investigator Site File (ISF) documents *I try to consistently work on initiatives that bring better learning opportunities and more defined competencies and standards to clinical research role *Excellent organization techniques and attentive in executing protocols. *Strong ability to liaise with Investigators, Monitors and patients. *Excellent understanding of Research terminologies and data. *Exceptional ability to adhere to ethical standards and all moral codes in the work place. *Excellent agility needed to perform various procedures or tasks at hand. *Great capacity and a strong enthusiasm to learn new things and retain information. *Always willing to give the best outcome to exceed the expectations of my superiors. I have a strong and burning desire to make use of my expertise and strong medical background in the field of clinical research and make a strong positive impact on the lives of future generations!
- Skills
- Clinical Research Medicine
Education
- Osmania Medical College, Hyderabad, India
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Bachelor of Medicine
Attended in 2013 - 2019
Field of study: Bachelor of Surgery (MBBS) - Potti Sri Ramulu Telugu University, Hyderabad
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Associate's degree
Attended in Dec 2014 - Sep 2017
Field of study: Kuchipudi dance
Positions
-
AbbVie
United States · Remote
-
Clinical Research Associate-Onchology
Jun 2023 - Present
Performing monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Other functions include:
-Performing site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance w/ scope of work and regulatory requirements (such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
-Working with sites to adapt, drive, and track subjects
-Administering protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
-Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
-Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
-Ensuring copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
-Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
-Collaborating and liaising with study team members for project execution support as appropriate.
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American College of Physicians
United States
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Member
Jan 2022 - Present
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ACRP - Association of Clinical Research Professionals
United States
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Member
Jan 2022 - Present
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Lybrate
India-Remote
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Attending Physician
Jan 2020 - Present
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VIARES
Vienna, Austria
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Clinical Research Associate Trainee
Dec 2021 - Jun 2023
*Experienced in Clinical Research Associate roles and responsibilities acquired at the VIARES Academy Vienna as a Trainee.
*Specified on industry competencies in Clinical Research, Pharmacovigilance and Regulatory Affairs.
Also, understood and gained more knowledge on the clinical Research topics ranging from:
*Medicines Development Process and Good Clinical Practice (GCP)
1.Background of medicines development
2.Research and discovery stage & product development
3.Clinical development
4.Regulatory submission, Health Technology Assessment, lifecycle management
5.ICH GCP and other applicable regulations
*Regulatory Environment in the EU and USA
6.Applicable national and international regulatory requirements including ICH GCP E6 (R2)
7.Requirements for audits and inspections
8.Need of compliance in all activities of Clinical research associate role
9.Sponsor’s obligation to develop and implement a quality assurance system including company-specific Standard Operating Procedure (SOPs)
10.Skills required before, during and after inspections/audits
11.Ability to recognize and deal with misconduct and suspected fraud
*Clinical Trial Design & Clinical Research Roles and Responsibilities
12.The Study Protocol
-Elements of a Study Protocol according to ICH GCP
-Trial Design
-Methodologies
13.Roles and Responsibilities
-Ethics Committees
-Sponsor / Monitor
-Investigator
-Competent Authority
*Selecting and Initiating Clinical Trial Sites
14.Understanding of how to assess an investigational site
15.Possible strategies for upgrading investigational sites (e.g. training, sourcing, equipment)
16.Development of the skills to plan, organize, conduct and document site initiation
*Monitoring and Closing Clinical Trial Sites
18.Understanding of how to effectively monitor an investigational site
19.Strategies for increasing site performance
20.Development of the skills to plan, organize and conduct and document monitoring visits, close-out visits