Julius Nfon Fomafung
Dayton,USA
Summary
Dynamic Senior Clinical Research Associate with extensive experience at Occlutech, excelling in strategic leadership and ICH-GCP compliance. Proven track record in enhancing patient recruitment by 40% and mentoring junior staff. Adept at managing cross-functional collaborations and ensuring data integrity through meticulous oversight and proactive communication.
Overview
14
14
years of professional experience
Work History
Senior Clinical Research Associate
Occlutech
Maple Grove, MN
06.2021 - Current
- Create, maintain, and manage relationships with internal cross-functional project team members.
- Managing study sites in the United States, Europe, and Canada.
- Providing remote and on-site support to sites.
- Assisting sites with regulatory submissions to the IRB, reviewing and monitoring research data, Serious Adverse Events (SAE), and reporting to the study trial team and regulatory bodies accordingly.
- Serving as a point of contact for 30 investigative sites.
- Serving as a clinical research project lead, finding suitable sites/investigators for the study, negotiating budgets with sites, reviewing contracts, collecting and filing study documentation.
- Qualifying, initiating, monitoring, and closing clinical investigative sites with the supervision of the Programs Manager and Vice President of Clinical and Regulatory Affairs.
- Managing study sites, reviewing study data, monitoring sites, preparing and maintaining proper status reports of activities at study sites through the duration of a clinical trial, and completing other technical tasks as requested by management.
- Complete source data verification (SDV), reviewing case report forms (CRFs) for accuracy and completeness.
- Develop/write relevant clinical study start-up documentation including ct.gov submission, study plans, and source worksheets.
- Submitting and managing study-level IRB/EC applications, assisting, and tracking all site-level IRB/EC approvals.
- Ensuring subject safety through diligent monitoring of the site’s compliance with study protocols and the collection of adverse event information.
- Monitoring Case Report Forms (CRF) for missing data.
- Assess compliance with investigational product handling procedures.
- Ensuring that all adverse events are accurately collected per Good Clinical Practice (GCP).
- Generating and reconciling queries for investigation sites to resolve/address inconsistent data.
- Provide answers to protocol-related questions under the supervision of the Programs Manager and Vice President of Clinical and Regulatory Affairs.
- Ensure that the Site Regulatory Documents are complete and current through trial.
- Maintain systems (eTMF, CTMS, EDC, Clinical trial.gov, IRB submissions, etc.) that track study progress.
- Mentored less experienced CRA staff.
Senior Clinical Research Associate/In-House Clinical Research Associate
Covance Clinical Development Service
Minneapolis, MN
01.2020 - 06.2021
- Established and maintained regular contact with approximately 30 investigators, vendors, and study sites to maintain scientific exchange, GCP/ICH/protocol compliance, and assessment of accrual rates.
- Reviewed monitoring visit reports and follow up letters while acting as Clinical Research Associate (CRA) point of escalation, tracking actual to projected variables related to CRA and site activities.
- Primary responsibility was for the leadership and oversight of the clinical teams, including site management, performance, and corresponding documentation.
- Ensured optimal study success by developing and implementing strategic clinical monitoring plans (CMP) with adherence to Good Clinical Practice, investigator integrity, and all study procedures.
- Trained and mentored new/junior CRAs and trained study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- As a CTL, I oversaw and led four clinical teams with a focus on directing site management, performance, and corresponding documentation with the execution of clinical trials at the site level.
- Conduct both on-site and remote monitoring visits to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
- Completed source data verification (SDV), reviewing case report forms (CRFs) and writing monitoring reports.
- Provided study-specific direction, training, and mentoring to six CRAs and support staff members and guided 10 other team members to drive top performance.
- Maintained accurate records of essential study materials and ensured proper filing and standardization across all studies.
- Maintained timely and effective communication among team members and site staff members with a focus on anticipating/identifying potential issues and implementing corrective actions for maximized efficiency.
- Partnered with the study management team to drive the effective execution of four global clinical studies and boost patient recruitment by 40%.
- Participated in the qualification of sites, site activation, site maintenance, and site closure.
- Developed study-specific templates.
- Prepared sites for BIMO sections.
Clinical Research Associate II
Regulatory Clinical Research Institute Inc (RCRI)
Minneapolis, MN
10.2018 - 01.2020
- Worked as an integral team member with respect to quality, integrity, timeliness, and cost-effectiveness when monitoring in conjunction with the in-house project teams to ensure that sites have adequate study supplies and resources for study execution.
- Developed recruitment strategies and an enrolment plan with the investigator and site staff to meet recruitment goals.
- Supported Project Teams with the management of research studies from study initiation through close-out activities.
- IRB/EC management, including site application assistance and approval tracking.
- Adhered to good clinical practices, study protocols, and applicable regulations.
- Prepared study progress reports for the project team and sponsor.
- Performed site qualification, initiation, interim monitoring (both remote and on-site), and study close-out activities.
- Reviewed invoices and managed clinical site payments.
- Completed source data verification (SDV), reviewing case report forms (CRFs) for accuracy and completeness.
- Ensured reported trial data were accurate and complete and participated in clinical data processes as needed.
- Supported study sites with recruitment strategies, tracking, and patient recruitment and discussed potential study risks and opportunities with the Project Manager and CTL.
- Provided site training as needed via phone or teleconference/web meeting.
Clinical Research Associate II
MedTrials
Dallas, TX
09.2015 - 10.2018
- Managed startup and completion of activities associated with clinical research studies per ICH regulations and ISO requirements.
- Created, maintained, and managed Trial Master Files for compliance managed clinical project functions through weekly project team meetings, study performance metrics creation, and reviewed study data for appropriateness.
- Performed study initiation activities, reviewed study protocol with site personnel, managed regulatory issues, and provided training on completion of the eCRF, leading to accelerated study timelines.
- Completed source data verification (SDV), reviewing case report forms (CRFs) for accuracy and completeness.
- Tracked and documented investigational product inventory, material accountability, and stability as required by the sponsor.
- Maintained accurate records of essential study materials and ensured proper filing and standardization across all studies.
- Perform study close-out visits per Clinical Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items.
- Perform remote/onsite visits (SQVs, SIVs, RMVs, COVs) as dictated by the monitoring plan.
Senior Clinical Laboratory Scientist
University of Minnesota Health
Minneapolis, MN
11.2011 - 09.2015
- Performed/analysed a variety of clinical laboratory testing in the areas of Clinical Haematology & Coagulation, Clinical Microbiology, Clinical Chemistry & Urinalysis Studies, Clinical Blood Banking & Serology Testing, and Clinical Immunology.
- Supervised clinical laboratory operations.
- Performing routine laboratory testing/functions to support scientific experiments and investigations.
- Mentored and taught aspiring lab scientists, medical interns, etc.
Education
Master of Business Administration - Healthcare
University of St. Thomas
St. Paul, MN11.2015
Bachelor of Science - Clinical Laboratory Science
Center for Allied Health – University of Minnesota
Minneapolis, MN08.2011
Minor in Management Science -
Carlson School of Business – University of Minnesota
Minneapolis, MN08.2011
Skills
- Medical/Scientific Development
- Clinical Operations
- Safety Monitoring and Evaluation
- Strategic Leadership
- Protocol Design and Development
- Phase I – IV Research Experience
- ICH-GCP Compliance/Guidelines
- Managing Technical Risk
- Continuous Integration/Continuous Delivery
- Continuous Improvement
- Cross-functional collaborations
- Data Review and Management
- Project/Time Management
- Coaching and Mentoring
- Communication
- Servant Leader
- Assurance (Q/A)
- Clindex (EDC)
- Wingspan (EDC)
- Rave (EDC)
- Veeva Vault (EDC)
- Epic (EMR)
- Gateway (EMR)
- Sunquest (LIS)
- Microsoft Teams
- Outlook
- WebEx
- Zoom
- OneNote
- Microsoft Office Suite
Affiliations
- American Society for Clinical Pathology (ASCP)
- Association of Clinical Research Professionals (ACRP)
Therapeutic Experience
- Device - Peripheral Venous Access: Class II & III Devices.
- Endocrinology - Diabetes Type I and Type II: Class III Devices.
- Investigational Device Exemption (IDE): Cardiovascular, Gastrointestinal.
- Hematology/Oncology: Breast Cancer, Colon Cancer, AML, CML
- In Vitro Diagnostics (IVD): Metabolic and Serology Class II and III Devices.
Languages
- English
- French
Volunteer Experience
- American Read and Count
- American Red Cross
- Simpson Homeless Shelter
Timeline
Senior Clinical Research Associate
Occlutech
06.2021 - Current
Senior Clinical Research Associate/In-House Clinical Research Associate
Covance Clinical Development Service
01.2020 - 06.2021
Clinical Research Associate II
Regulatory Clinical Research Institute Inc (RCRI)
10.2018 - 01.2020
Clinical Research Associate II
MedTrials
09.2015 - 10.2018
Senior Clinical Laboratory Scientist
University of Minnesota Health
11.2011 - 09.2015
Master of Business Administration - Healthcare
University of St. Thomas
Bachelor of Science - Clinical Laboratory Science
Center for Allied Health – University of Minnesota
Minor in Management Science -
Carlson School of Business – University of Minnesota
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