Fola Kareem

About Fola Kareem

A Skilled Senior Clinical Research Associate with several years of experience in the clinical research industry. Expertise in multiple Therapeutic Areas including Vaccines, Respiratory, Dermatology, Rare Diseases and Cardiology. Experienced in multiple pharmaceutical and medical device protocols, activities such as source data verification, eTMF maintenance, ISF binder review, knowledge of ICH GCP and ISO 14155 guidelines.

Experience

1. Senior Clinical Research Associate

   Kcr

   Jan 2016 — Present · Boston, MA, US

   Responsible for all aspects of study site monitoring, including routine monitoring, close out visit, conducting pre-study and site initiation visits as outlined in the Clinical Monitoring Plan (CMP), applicable SOPs and regulatory guidelines.•Monitor activities at clinical study sites to ensure adherence to Good Clinical Practice (GCP) guidelines, SOPs, and study protocols.•Assess drug storage conditions and procedures to check adherence to standard protocols.•Assure timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).•Maintaining awareness of key study performance indicators for sites, e.g. patient enrollment, SAEs.•Works as an integral study team member with respect to quality, integrity of the data timelines, and cost effectiveness while monitoring.•Assists the investigational site in the management of timely query resolution.•Assists project teams by ensuring that all data is collected and submitted within appropriate timelines and communicate these timelines to the investigational sites.•Coordinate and generate reports as required and handled multiple projects as well as perform a variety of complicated tasks such IVRS data verification for drug accountability.•Participate in the study development and start-up process, including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.•Collaborates with project teams to contribute research methods for trials.

Education

• University of Lagos

  Bachelor of Science - BS

  2006 — 2010