BRIANA JACKSON
Merrillville,USA
Summary
Proactive and determined Clinical Trial Manager with 15 years of experience in clinical research. Skilled in managing site operations, supervising staff, and conducting risk assessments. Strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm. Known for adaptability, creativity, and a results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager
Pfizer
11.2019 - 02.2023
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Facilitated clear communication between study teams, and investigator sites to maintain alignment on project goals and expectations.
- Oversaw daily operations of assigned tasks by implementing effective team management, conducting IRB submissions, and managing vendor relationships, increasing operational efficiency by 10%.
- Assisted with study start-up activities.
- Reconciled and managed site and vendor invoices,
- Collaborated cross functionally with other departments (Medical Affairs, Regulatory Affairs, Data Management, Pharmacovigilance, etc.), during the lifecycle of the study.
- Identified study risks, developed, and implemented mitigation strategies; proactively managed the study and associated risks through key risk and performance indicators.
- Escalated any risks to the project manager that may affect study deliverables, and activities /requests which may be out of the contract scope.
- Participated in and/or led key study meetings (vendor, Investigator, CRO, etc.).
- Participated in user acceptance testing (UAT).
- Provided status updates on clinical deliverables and risks to internal and external stakeholders.
Senior Clinical Research Associate
Provident Research
10.2017 - 11.2019
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Participated in conducting feasibility studies
- Monitored non-interventional, observational, and registry studies.
- Conducted both blinded and unblinded monitoring visits.
- Monitored medical device studies, performed risk-based monitoring, provided site updates, and escalated site issues to the project team as needed.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Senior Regional Site Manager
Ascent Services Group
05.2016 - 04.2017
- Monitored non-interventional, observational, and registry studies.
- Conducted Pre-Study, Site Initiation, Interim Monitoring, Remote Monitoring, and Close-out visits.
- Provided study training and re-training to site staff.
- Communicated with study sites regarding updates and followed up on open issues.
- Monitored medical device studies, performed risk-based monitoring, provided site updates, and escalated site issues to the project team as needed.
- Developed strong relationships with clients through consistent communication of project updates and prompt resolution of concerns or issues.
Lead Clinical Research Associate
Worldwide Clinical Trials
03.2015 - 04.2016
- Provided input on the development of CRFs and CRF guidelines.
- Participated in conducting feasibility studies.
- Conducted oversight visits to review CRA performance and ensure adherence to the Monitoring Plan, Protocol, and study compliance.
- Participated in training vendors and site staff on study requirements.
- Reviewed monitoring reports and follow-up correspondence.
- Managed 12 CRAs and assigned them to Investigator sites
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Senior Clinical Research Associate
Worldwide Clinical Trials
02.2014 - 04.2016
- Monitored non-interventional, observational, and registry studies.
- Trained and mentored new CRAs.
- Conducted Pre-Study, Site Initiation, Interim Monitoring, Close-Out, and Remote Monitoring visits.
- Conducted feasibility studies.
- Communicated with study sites regarding updates and followed up on open site issues.
- Conducted initiation, monitoring, and closeout visits to verify study procedures, regulatory documents, and data completion.
Education
Master of Business Administration (MBA) -
Indiana Wesleyan University
Marion, INBachelor of Science (BS) - Business Administration
Calumet College of St. Joseph
Whiting, INNursing Technical Certificate - Licensed Practical Nurse
IVY Tech State College
Gary, INSkills
- Staff Supervision
- Microsoft Office
- Training and mentoring
- Adverse event reporting
- CTMS
- Clinical operations
- Multitasking Abilities
- Leadership skills
- Safety reporting
- Trial management
Certification
Licensed Practical Nurse (LPN) in Indiana and Illinois.
Timeline
Clinical Trial Manager
Pfizer
11.2019 - 02.2023
Senior Clinical Research Associate
Provident Research
10.2017 - 11.2019
Senior Regional Site Manager
Ascent Services Group
05.2016 - 04.2017
Lead Clinical Research Associate
Worldwide Clinical Trials
03.2015 - 04.2016
Senior Clinical Research Associate
Worldwide Clinical Trials
02.2014 - 04.2016
Bachelor of Science (BS) - Business Administration
Calumet College of St. Joseph
Nursing Technical Certificate - Licensed Practical Nurse
IVY Tech State College
Master of Business Administration (MBA) -
Indiana Wesleyan University
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