Clinical Research Manager
Resume:
SUMMARY
SKILLS
EXPERIENCE
SIDDHI
PATEL
*************@*****.***
HASBROUK HEIGHTS, NJ 07604
MS in Biotechnology & MS in clinical research Management with a coursework training experience in Clinical trial management in accordance with the applicable ICH, GCP, FDA and local regulation.
• Patient Recruitment
• Redcap (BASIC)
• Certified Human subject protection
• Certified ICH-GCP
• Regulatory Binders
• MS Excel,Word & PowerPoint
• GCP Auditing
• Data Entry
• Query resolution
• Time Management
CLINICAL RESEARCH-VOLUNTEER (J&J COVID 19 VACCINE) 12/2020 to Current RWJ - Rutgers - New Brunswick, NJ
• Perform source document verification.
Review of site regulatory documentation in accordance to Standard Operating Procedures, Good Clinical Practice and regulatory guidelines.
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• Multiple clinical site source document auditing.(3 sites)
• Review of study specific documents and Case Report Forms.
• Review of monitoring reports and informing the CSM of any critical findings.
• Review medical records and subject information for completion.
• Ensure ICF is collected from all subjects as per protocol.
• Ensure all documents are filed as per regulatory requirements.
• Prepare and assist in facilitation for routine monitoring visits.
• Assist regulatory coordinator in reviewing regulatory binders.
• Manage study related binders.
RESEARCH PROJECT -CLINICAL TRIAL MANAGEMENT 09/2020 to Current Project (Course) - Developed GCP Audit Plan
Prepared a project plan for assessing the compliance status of a clinical site that the company intends to use, or is currently using to conduct clinical trial.
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• Inspection of site for GCP compliance.
RESEARCH PROJECT -CLINICAL TRIAL MANAGEMENT 08/2019 to 12/2019 Project (Coursework) - Rutgers
Screened dummy subjects for eligibility using protocol specific inclusion and exclusion criteria.
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• Assisted project team with study specific documents
• Collected Informed consent forms from dummy subjects.
• Supported in developing source documents in REDCAP software. Supported in managing all draft study records and maintained all source documents and study files as per project requirements.
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Entered all the draft information from source documents generated from the sites into REDCAP software.
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PROJECT COORDINATOR 04/2018 to 08/2018
Grace Home Healthcare Services - Princeton, NJ
• Perform all coordinating duties when necessary.
EDUCATION AND
TRAINING
Review and direct client's case management notes, documenting change of aide, change in service, telephone complaints etc.
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Supervise the completion of intake forms and their appropriate routing for admission approval.
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Supervise the scheduling of replacement workers as needed and input of the scheduling information.
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• Handle matters related to staff and the patient they serve. RESEARCH ASSOSIATE 06/2012 to 08/2012
Anand Agricultural University - Anand, Gujrat
Did research on molecular characterization of rice (Oryza Sativa L.) genotypes with varying pericarp color using INDEL and SSR markers.
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Research was done to study genetic diversity of 19 pigmented rice genotypes to detect the efficiency of two markers INDEL and SSR.
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• Research results can be used to predict potential genetic grains to create hybrid.
• Assessment of genetic diversity among pigmented rice was done.
• Research paper was successfully published in emirates journal of food and agriculture. The project report will be a key reference point for plant breeders for creating hybrid plants
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• Instrumentation used – GEL Electrophoresis, PCR, and Spectrophotometry.
• Isolation of Genomic DNA was done by CTAB method.
• Data analysis was done using Electrophoresis.
• Two software's used for data analysis were SAS 9.1.3 AND NTSYS software. OPERATIONS MANAGER 08/2018 to ongoing
Anita Dongre - New York, NY
Responsible for the administration of new hire paperwork and onboarding of all store employees.
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• Oversee the training and development of office staff. Conduct timely meetings with the team to get the feedback on the store operations and merchandise.
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• Build and maintain all store schedules and approve timecards. Monitor and track timely maintenance of shop equipment Ensure security of all company assets including financial resources, merchandise, supplies and findings
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Monitor and maintain all issues related to the technological aspects of the store through active communication with relevant support departments to address issues
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Ensure customer concerns and complaints are addressed and resolved in an efficient and timely manner with a high degree of discretion and flexibility,
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• Timely followup of accounting,and year end closures. Mahaveer Jain College - Bangalore India
Bachelor of Science
Biotechnology, 2010
• 3.5 GPA
Ramnarainan Ruia College - Mumbai,India
Master of Science
Biotechnology, 2012
• 3 GPA
Rutgers, The State University Of New Jersey - Newark, NJ Master of Science
Clinical Research Management - Ongoing
• 3.8 GPA
Citi Programme
Certificate Good Clinical Practice
CERTIFICATIONS
2020
Ecornell
Pharmaceutical Management Certification
2019
GCP -Good Clinical Practice Certification
Pharmaceutical Management Certification
Human Subject Protection Certification
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