Clinical Research Associate

Titilayo ALUKO

CLINICAL RESEARCH ASSOCIATE

****************@*****.***

Houston, Texas 77065

PH: 832-***-****

PROFESSIONAL SUMMARY

• A seasoned clinical research monitor with extensive experience in site management, site monitoring and clinical trial conduct about 4 years in multiple therapeutic areas and across multiple phases of clinical research with broad range of therapeutic experience.

• Proficient in the technical/scientific knowledge required for comprehension and execution of clinical protocols.

• Possession of the requisite organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budgets.

• Superior written and verbal communication skills.

• Ability to work in a matrix and fast - paced environment.

• Ability to constructively interact directly with various project team members.

• Highly proficient in MS Office, eTMF, CTMS and EDC systems THERAPEUTIC AREAS

• Cardiovascular

o Congestive heart failure

o Cardiac sensors

• Infectious Diseases

o RSV

o Hepatitis A and B

o COVID 19

• Medical Device

o Cardiovascular sensors

PROFESSIONAL EXPERIENCES

Edwards Lifesciences January 2021 to Present

Clinical Research Associate I

Perform all types of monitoring visits (Pre study site visit, Site initiation visit, interim monitoring visit, and close-out visits) to verify compliance with study protocol requirements and regulatory requirements, as well as ICH/GCP guidelines.

Support the site identification process.

Participates in the design, planning, implementation, and overall direction of clinical research projects.

Responsible for the development of study documents (e.g., monitoring visit trackers)

Conduct monitoring visit to review source documents and case report forms to ensure that essential documents are current and complete and filed in the site’s regulatory binder.

Identify discrepancies and provide additional training and initiate corrective action as required.

Follow-up with the assigned sites to assist in resolution of significant issues noted during site monitoring visits.

Maintain up-to-date documentation of the Trial Master File and verify that the regulatory documents are up to date and complete prior to archiving.

Acts as a main line of communication between the internal study team and the study site staff involved in the study.

Monitor study subject enrollment and study progress at study sites.

Perform device accountability and the supply of study materials as applicable.

Responsible for data management activities such as data entry in the database, data query resolution, and data clean-up activities.

Moderna

Clinical Research Associate I January 2020 to December 2020

Acted as a support for assigned sites and clinical study team. Maintains status updates as per direction of Clinical Project Manager of assigned project.

Assisted with study documentation development and facilitates preparation of educational training tools, newsletters, study logs, and other relevant documents

Managed all activities associated with clinical study site management to include but not limited to: monitoring, data review, site status, site compliance and metrics, site payment processing and tracking. .

Corresponded (verbal and written correspondence) with the site personnel and serves as a site resource

Provided accurate information and study documentation to clinical study sites.

Processes site requests in a timely fashion, including review of Informed Consent Forms, site budgets, patient enrollment questions, etc.

Conducted site personnel training on the study protocol and procedures.

Provided administrative support for study-related meetings.

Coordinated shipments and returns of study materials.

Provided timely update to the Study Management team

Monitored Institutional Review Board approvals from study sites to ensure that participating study sites have required approvals.

Organized, compiled, and distributed clinical study documents (protocol, Case Report Forms, ICF, study procedures, agreements, etc.).

Tracks receipt of proper study documentation (IRB approval letters, Informed Consent materials, signed Clinical Study Agreements, Confidentiality Agreements, etc.). Filed all documents in accordance with company procedures or CTMS requirements.

Oversees timely data entry and source submission by the study sites. Perform data review for assigned sites on a weekly basis. Support cohort/data cleaning for analysis and publications.

Manages and updates study files, as directed.

Conducted both onsite and remote monitoring visit as well as Risk Based Monitoring as needed.

Coordinated Adverse Event reporting for studies and ensured all applicable information is received.

Seeks guidance from Clinical Research Manager for additional assignments. Aker Biomarine

Clinical Trial Associate June 2018 to December 2019

Reviewed, filed, and tracked study documents collected by the field monitors (CRA), provided document review assistance, and initiated appropriate follow-up as needed.

Assisted with managing the ordering/dispatch and tracking of study materials (e.g., binders, notebooks, lab supplies) as appropriate.

Reviewed Investigator/Site invoices for accuracy and reconcile against the case report forms (CRFs) and budget for payment submission.

Assisted with tracking central and local IRB submissions and approval.

Assist with tracking of the collection of required documents during site start-up.

Served as a contact to clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)

Routed study documents to the appropriate personnel for validated digital signatures.

Provide support to the CTM and project team with meeting coordination, agenda preparation and generation of meeting minutes as assigned.

Provided support to the clinical team as needed.

Updated all relevant tracking system on an ongoing basis.

Performed regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS)

Collected, updated/amended regulatory documents in collaboration with CRAs as needed.

Reviewed recruitment plan and enrollment updates and addressed/resolved issues pending from the previous visit.

Assessed drug/study supply status and requested outstanding documents.

Maintained a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and specific procedure (e.g., Monitoring Plan, study trackers) EDUCATION BACKGROUND

Bachelor’s degree in computer science

Ekiti State University, Nigeria December 2014

PROFESSIONAL CERTIFICATIONS

Good clinical practice (GCP).

Skills/Technology:

EDC (Medidata Rave, Inform, Oracle Clinical)

CTMS (Veeva Vault, Open Clinical)

Good Clinical Practice.

ICF review and development.

IVRS/IWRS

Device accountability.

Microsoft Word, Excel, Power Point, One Note.

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