Jamika Howell

Clinical Research

Talent

Reading, ReadingMember since August 20, 2024

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About

Hi 👋🏾 My name is Jamika, and I am a professional with over 6 years of experience in the Clinical Research Industry.

Profession 👩🏾‍🏫

With a solid background in clinical research, I have a proven track record of managing and coordinating all aspects of clinical trial operations. My expertise spans managing and maintaining clinical trial documentation, assisting with regulatory submissions, coordinating investigator meetings and shipments, and managing study finances. I am well-versed in ensuring compliance with ICH-GCP and relevant local regulations, as well as adhering to departmental SOPs and guidelines.

Throughout my career, I have had the opportunity to work across multiple therapeutic areas such as Oncology, Rare Diseases, Dermatology, and Immunology, focusing on phase 2-3 studies. My skill set includes proficiency in IRT Systems, Trial Master Files (TMF), TE tracking platforms, managing import/export license applications, shipping solutions, transit monitoring, and much more.

Currently, I am a Logistical Coordinator at ICON/Sanofi, where I handle clinical distribution planning, logistics management, and TMF responsibilities. I oversee the start-up, maintenance, and archiving of essential documents from investigative sites. In my role, I have successfully managed the accurate updating and maintenance of over 15 studies simultaneously.

Feel free to connect if you'd like to discuss clinical research, exchange industry insights, or explore potential collaborations!

Experience

Logistical Co-Ordinator II (ICON/under contract to Sanofi) May 2022 – Present

Oversaw start-up and maintenance of studies in CTMS and TMF, and IRT Systems
Ensured compliance with GxP and regulatory requirements
Coordinated the import and export of clinical study supplies, including IPs, non-IPs, medical devices, laboratory kits, and equipment
Prepared and submitted import/export license applications, amendments, and renewals to competent authorities
Liaised effectively with clinical teams, customs authorities, depots, third-party vendors, and couriers for logistics and distribution of study supplies
Maintained detailed tracking of study-related shipments, finances, and import/export license validity
Adhered to TMF quality control checklists
Created and managed a Temperature Excursion management plan
Managed the review and assessment of Temperature Excursions reported to the clinical trial supplies team
Conducted regular risk management assessments to review and mitigate risks

Logistical Co Ordinator I / Senior Clinical Project Assistant (LabCorp/under contract to Sanofi) May 2021 – May 2022

Updated and maintained the eTMF (Veeva/CTP).
Tracked supplies stored with sub-contractors and managed effectively.
Supported the setup and monitoring of IRT systems.
Reconciled and maintained all IP for all sites and studies using appropriate IRT systems (ALMAC, Clinphone, EndPoint).
Coordinated and served as the main local contact for IMP complaints.
Maintained detailed tracking of study-related shipments, finances, and import/export license validity.
Prepared, collected, and tracked master study-level documents, reviewing regulatory and non-regulatory documents.
Collaborated with other company functional areas and study vendors to oversee all aspects of study activities and ensure timelines were met.

Senior Project Co-Ordinator / Assistant (MD Group) Aug 2020 – April 2021

Managed all administrative aspects of the set up and conduct of clinical trials.
Maintained and updated study and vendor trackers.
Managed patient finance stipend and reimbursements, tracking invoices.
Coordinated with sites to manage discrepancies.
Worked with various sites and projects throughout the work.
Sent and tracked equipment and confidential documents.
Managed vendor invoices and Purchase Orders (POs)