Jeseraire Francis
Summary
Experienced clinical manager with a proven track record spanning over 10 years in research and global clinical trials. Skilled in cross-team collaboration, leadership, communication, presentation, vendor management, and ensuring compliance with GCP guidelines. A proactive problem solver with a talent for innovation. Proficient in Microsoft Suite and holds a Bachelor's degree in health science from Mercy College.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager
Menarini-Stemline
01.2022 - Current
- Manages start-up activities for Phase I, II, and III trials including but not limited to study feasibility, site and vendor selection, preparation, and/or follow-up of site regulatory packages in coordination with other clinical operation staff and other departments.
- Designs and collaborates in the production of study plans including but not limited to study manuals, project plans, project tools, informed consent template, case report forms, case report completion guidelines.
- Contribute to bid process and selection of Contract Research Organization (CRO).
- Manages interface meetings with CROs by attending weekly and ad-hoc meetings to ensure Sponsor expectations and timelines are met.
- Serves as a point person between site related issues and study procedures
- Follows escalation process to inform key stakeholders of study issue(s).
- Reports study updates and discuss strategies to key stakeholders and core clinical team members on a weekly and/or bi-weekly basis.
- Collaborates with other cross functional team members to meet study timelines.
- Ensures audit-ready condition of clinical trial documentation including electronic trial master files (eTMFs); reviews monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assist in the planning of regulatory or ethics committee activities, as appropriate.
- Provides guidance and mentorship to Clinical Trial Assistant and Trial Managers.
- Supports the Clinical Program Lead and/or Clinical Trial Lead with the development, management and tracking of the trial level budget(s) including forecast, and annual budget reviews.
- Additional role(s) held:2021-2022, Associate Project Manager, Stemline Therapeutics, New York, NY USA
- Additional role(s) held: 2018-2021, Clinical Trial Assistant
- Supported project management and clinical operation study team members in overall logistics for clinical trials.
- Managed clinical trial documents on all ongoing studies in the electronic trial master file (eTMF) including clinical study site documents, email correspondences, training materials, and other study documents.
- Trained new team member on the eTMF as the Subject Matter Expert (SME)of the trial master system.
- Created agenda and taking minutes across all clinical trials
- Generated and maintained study trackers for all ongoing trials
- Supported the Lead Clinical Research Associate (CRA) and CRAs with following up through resolution on action items. This consist of establishing a relationship with difficult sites to resolve on-going pending items.
- Developed study plans for start-up trials.
- Reduced operational costs through effective budget management, negotiation with vendors, and careful allocation of resources.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Evaluated vendor performance regularly to ensure high-quality services were provided throughout the duration of the clinical trial.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Championed continuous improvement initiatives within the organization by sharing best practices and lessons learned from previous trials with colleagues and team members.
- Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
- Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
- Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Supported the preparation of clinical study reports by providing accurate data analysis and interpretation for inclusion in final documentation.
- Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Gathered, processed, and shipped lab specimens.
- 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.
- Complied with research protocols by providing ongoing quality control audits.
- Collected, evaluated, and modeled collected data.
- Reviewed referral information and kept track of intakes from various referral sources.
- Facilitated focus group sessions with project patients.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Research Assistant
John Hopkins University
01.2013 - 01.2018
- Corresponded with Principal Investigator with all research clinical studies.
- Implemented research studies related to cognition and language using variety of behavioral and neuroscience methods.
- Managed analyzing data using EEG/ eye tracking equipment, behavioral observation data collection, and pre/post testing assessment.
- Organized data transfer, data maintenance, created and maintained research logs, video coding, report safety events, and ensure strict adherence to research protocols.
- Managed recruiting new participants (neurotypical and non-neurotypical)
- Trained new hires on EEG equipment and software.
- Delivered 1:1 instruction to a person with autism.
- Created and maintained educational materials
- Provided in-home habilitation services that include overseeing client evening routine and assisting with personal hygiene
- Monitored treatment specific to the clients' needs
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
- Organized research materials, maintaining a well-ordered workspace conducive to productivity.
- Maintained open lines of communication with project leads and team members for effective collaboration on common goals.
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
- Monitored project timelines, ensuring timely completion of tasks while maintaining high-quality output.
- Contributed to the publication of research articles in peer-reviewed journals, showcasing expertise in various topics.
- Collaborated with multidisciplinary teams to develop innovative research methodologies and strategies.
- Synthesized complex information into clear summaries to make findings accessible to diverse audiences.
- Managed laboratory equipment and resources, ensuring proper maintenance and optimal functionality.
- Utilized statistical software for data analysis, generating accurate insights into complex datasets.
- Supported grant writing efforts, securing essential funding for groundbreaking research projects.
- Implemented rigorous quality control measures, elevating standard of research outputs.
- Contributed to development of research proposals, aligning with strategic objectives and securing project approvals.
- Pioneered use of virtual collaboration tools, enhancing team productivity and engagement in remote settings.
- Streamlined project workflow, optimizing team efficiency through development of detailed scheduling and tracking systems.
- Analyzed complex data sets to uncover critical insights, driving direction of research projects.
- Elevated team's research capabilities by conducting comprehensive training sessions on advanced analytical software.
- Enhanced research accuracy by meticulously organizing and analyzing data sets.
- Managed research databases with utmost diligence, ensuring data integrity and security.
- Conducted extensive literature reviews to support ongoing research projects, significantly expanding team's knowledge base.
- Translated research findings into actionable recommendations, influencing policy and practice.
- Coordinated with external research partners to ensure seamless integration of collaborative projects.
- Enhanced participant recruitment strategies, leading to more diverse and representative study samples.
- Identified and resolved data discrepancies, ensuring highest level of accuracy in research outcomes.
- Spearheaded development of novel research methodology, setting new standard for future projects.
- Customized research instruments to better capture nuanced data, enriching depth of research analysis.
- Improved data collection methods with introduction of innovative survey techniques.
- Facilitated cross-disciplinary research collaborations, broadening scope and impact of research findings.
- Optimized lab equipment usage, significantly reducing operational costs and downtime.
- Recorded and analyzed data to produce reports of results.
- Participated in research projects by designing and executing experiments.
- Participated in lab meetings and project presentations.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Troubleshot and resolved equipment and process issues.
- Trained and supervised junior technicians in laboratory protocols.
Instructional Therapist Assistant
Qsac (Quality Service for the Autistic Community)
01.2012 - 05.2013
- Organized daily routines with the autistic adults
- Supported in daily goals for autistic adults to accomplish
- Managed volunteer worksite for the adults to help their community
- Promoted independence's of activities for daily living for autistic adults
- Supported therapists in conducting comprehensive evaluations to assess patients'' needs, strengths, and areas for improvement.
- Advocated for patients'' needs by maintaining open lines of communication with caregivers, ensuring all parties were informed of therapy progress and potential challenges.
Education
Bachelor - Health Science
Mercy College
DobbsFerry, NY01.2011
Skills
- Training and mentoring
- Clinical trial oversight
- Document review
- Site selection
- Clinical operations
- Organizational skills
- Effective communication
Certification
None
Languages
English, native
Spanish, beginner
Publications
O'Grady J, Keller K, Kennedy S, Francis J, Gordon B, Davis K, EEG NET Tolerance Training for an Adult with Autism Spectrum Disorder, Neurology, 2018
Davis K, Kennedy S , O'Grady J, Bontemps J, Francis J, Gordon B, Assessing the Appropriateness of Catatonia Rating Scales in Describing Motor Abnormalities In A Man With Autism Spectrum Disorder, Neurology,2018
Timeline
Clinical Trial Manager
Menarini-Stemline
01.2022 - Current
Research Assistant
John Hopkins University
01.2013 - 01.2018
Instructional Therapist Assistant
Qsac (Quality Service for the Autistic Community)
01.2012 - 05.2013
Bachelor - Health Science
Mercy College
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