Abby Bakare
Chicago,IL
Summary
Versatile clinical Trial Manager, knowledgeable about conducting clinical research in line with FDA and ICH-GCP guidelines. Highly organized and thorough with good planning and problem-solving abilities.
Overview
10
10
years of professional experience
Work History
Clinical Trial Manager
Syneos Health
08.2021 - Current
- Reviews site-level clinical documents (ICFs, IRB approvals, etc.) and clinical monitoring reports; reviews and maintains study-level clinical plans (including, but not limited to, site monitoring plan, deviation plan, data management plan)
- Manages the Trial Master File (TMF) and performs ongoing quality reviews
- Supports Health Authority Inspections and Inspection preparedness, including participating in co-monitoring activities which may involve traveling
- Escalates identified risks to the Head of Clinical Operations or appropriate stakeholder and follow through to resolution
- Supports preparation of data and other information for internal and external presentations; participates in internal and external team meetings to share updates on the progress of activities
- Contributes to the development of study training and project management materials including databases and trackers
- Responsible for the day-to-day progress of clinical trials and acting as the clinical pivot for the trials
- Ensures clinical sites are conducting research according to the clinical protocol, local regulations, Code of Federal Regulations (CFR), ICH, and Good Clinical Practice (GCP) guidelines
- Manages site activities including monitoring, recruitment, enrollment, data collection, and data entry
- Participates in vendor management and oversight.
Senior Clinical Research Associate
PPD
07.2019 - 08.2021
- Attended meetings to ensure an understanding of procedures and forms for the collection, processing, and storage of clinical research specimens
- Prepared/revised/reviewed SOPs, Work Instructions, and Lab Manuals
- Identified problems and communicate them to the team members
- Assisted in the planning and execution of verification and validation experiments
- Enhanced and optimize in vitro assay test methods
- Demonstrated appropriate use, care, and maintenance of all equipment in the lab
- Evaluated reagents for assay development and reagent stability
- Responsible for placement and organization of supplies, etc
- Inappropriate locations or storage bins within the lab.
Clinical Research Associate II
PPD
05.2018 - 07.2019
- Verified that the process of obtaining informed consent has been performed and documented for each subject/patient, as required/appropriate
- Demonstrated diligence in protecting the confidentiality of each subject/patient
- Assessed factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
- Conducted Source Document Review of appropriate site source documents and medical records
- Evaluated overall performance of site and site staff and provided recommendations regarding site-specific actions; immediately communicated/escalated serious issues to the project team and developed action plans
- Provided guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Verified that required clinical data entered in the case report form (CRF) is accurate and complete
- Performed site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely)
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Ensured regulatory, ICH-GCP, and protocol compliance
- Utilized available hardware and software to support the effective conduct of the clinical study data review and capture.
- Reviewed data queries and listings and worked with study centers to resolve discrepancies.
Clinical Research Associate I
PPD
11.2016 - 05.2018
- Interacted with internal workgroups to evaluate needs, resources, and timelines
- Reviewed progress of trials and initiated appropriate actions to achieve target objectives
- Conducted, reported, and followed up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC)
- Responsible for all aspects of registry management
- Independently performed CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned
- Organized and made presentations at Investigator Meetings
- Participated in the development of protocols and Case Report Forms
- Participated in writing clinical trial reports as assigned.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
Clinical Research Coordinator
Cleveland Clinic
05.2014 - 11.2016
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Ensured data accuracy with source documentation
- Ensured documentation processes are followed according to GCP
- Maintained all necessary patient source documents for assigned studies
- Obtained data, including images, specimens, and medical records, from outside facilities, as needed
- Fulfilled sponsor requirements related to reportable information, including AE, unanticipated problems, and other information required by the sponsor protocol
- Ensured all protocol procedures are ordered and completed as specified in the protocol
- Assembled lab kits and other supplies in preparation to obtain required bio-specimen samples and transported them to appropriate laboratories for processing, shipped samples externally according to IATA requirements
- Optimized the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team, and institution according to protocol and regulatory requirements.
Education
Bachelor of Science - Nursing
LAUTECH
NGMaster of Science - Leadership And Management
Western Governors University
Salt Lake City, UTSkills
- Good Clinical Practices
- Study Protocols
- Protocol Review
- Informed Consent
- Critical Thinking
- Problem-Solving
- Clinical Trial Expertise
- Trial Management
- Documentation Requirements
- Records Management
Timeline
Clinical Trial Manager
Syneos Health
08.2021 - Current
Senior Clinical Research Associate
PPD
07.2019 - 08.2021
Clinical Research Associate II
PPD
05.2018 - 07.2019
Clinical Research Associate I
PPD
11.2016 - 05.2018
Clinical Research Coordinator
Cleveland Clinic
05.2014 - 11.2016
Bachelor of Science - Nursing
LAUTECH
Master of Science - Leadership And Management
Western Governors University