Bhagyasri Jain Dharmaraj
Mars,PA
Summary
Results-driven Clinical Research Manager known for high productivity and efficient task completion. Possess specialized skills in clinical trial management, regulatory compliance, and data analysis. Excel in communication, leadership, and problem-solving to achieve project objectives on time and within budget
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Manager
University of Pittsburgh
2021.08 - Current
- Leading multi-site studies, working cross-functionally with physicians, biostatisticians, physical therapists, and research associates to deliver clear operating procedures and data monitoring guidelines
- Oversee conduct and management of various Pain management trials
- Oversee hiring, performance management, and new hire on-boarding, on-going staff development
- Collaborated in obtaining and updating all site-specific study requirements including IRB submissions
- Prepare for and guide coordinators, and investigators during NIH and sponsor monitor visits
- Contributed to bring up the department BRIMR ranking from #15 to #5 among the top five NIH-funded anesthesiology departments in the nation
- Carried out visits for 250+ chronic pain participants by running EKGs, Quantitative sensory tests and specimen collection and ensure compliance with protocol guidelines
- Managed data collection and developed analysis reports to the study team and NIH to facilitate track records of participant recruitment, enrollment, and retention rates.
Associate Operations Specialist
Quintiles Research
2014.02 - 2014.08
- Receive, triage, review and process data from various sources on time, within budget and meet quality standards
- Performed data entry for tracking and safety database, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines
- Receive and document incoming faxes or emails from investigative sites or other sources reporting Lifecycle Safety data
- Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
Clinical Research Associate
Quintiles Research
2007.05 - 2008.11
- As an in-house support for a study with indication of Schizophrenia, assisted in Site Initiation preparation, Investigational Product (IP) release documents, updating safety reports & patient visit logs, Ethics committee (EC) submissions, follow up with sites, maintain Central Investigator Files (CIF) & Audit preparations for the study
- Executed various Site Selection, Monitoring & Closure Visits for studies with the indications like Schizophrenia, Schizoaffective disorder & Ulcerative colitis
- Accountable for follow up with sites for patient visit logs, EC submission dates, filing & maintain the CIF files, collecting IP release documents, preparing for EC submissions and also assisting in audit preparations.
Education
Masters Certificate in Clinical Research Management -
Indian Management School and Research Centre
MumbaiBachelor of Pharmacy (B. Pharm) -
Rajiv Gandhi University of Health Sciences
BangaloreSkills
- Clinical Research Management
- Pain Management Trials
- IRB Submissions
- NIH Monitor Visits
- EKGs
- Quantitative Sensory Tests
- Specimen Collection
- Data Collection
- Participant Recruitment
- Enrollment and Retention
- Data Entry
- Ethics Committee Submissions
- Site Selection
- Monitoring and Closure Visits
- Audit Preparations
- Document Management
- Training and mentoring
- Teamwork and Collaboration
- Enrollment coordination
Certification
ACRP-CP, In Progress, 08/2024
Publications
BACPAC: Protocol and Pilot Study Results for a Randomized Comparative Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect., Wasan, Ajay D et al., Pain medicine (Malden, Mass.), 01/30/2023, 10.1093/pm/pnad006
Websites
Timeline
Clinical Research Manager
University of Pittsburgh
2021.08 - Current
Associate Operations Specialist
Quintiles Research
2014.02 - 2014.08
Clinical Research Associate
Quintiles Research
2007.05 - 2008.11
Masters Certificate in Clinical Research Management -
Indian Management School and Research Centre
Bachelor of Pharmacy (B. Pharm) -
Rajiv Gandhi University of Health Sciences
ACRP-CP, In Progress, 08/2024
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