OLA AKANDE

Email: ac00h2@r.postjobfree.com

Phone: (**3) 592 - 6708

SUMMARY

•Bachelor’s Degree in Biology with extensive clinical coordination/research associate experience including medical device/drug management including within research laboratory environments.

•Helped manage medical device/drug supply through order/processing for clinical trials that involved advanced therapeutic and non therapeutic drugs.

•Provided adequate information as the Clinical Research Specialist/Associate about site visits, data, adverse events, ICF, overall process of how the lab was run.

•Collaborated with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.

•Prepared other study materials as requested by the PI which may include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

•Established and organized study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

•Strong knowledge in Good Clinical Practice (GCP) & EDC.

•Helped to mentor and train newly hired research study associates.

SKILLS

•Microsoft Office Suites; Word, PowerPoint, Excel, and Outlook, Medidata Rave, GCP, GLP, SOPs, eTMF, and EDC.

EXPERIENCE

Beekley Medical, Bristol, CT

Clinical Research Specialist/Associate April 2017 - July 2017 (Contract)

• Writing medical device trial methodologies (Procedures)

• Identifying and briefing appropriate trial investigators (Clinicians/Principal Investigators)

• Setting up and disbanding trial study centers

• Designing trial materials and supplying study centers with sufficient quantities of medical devices

• Providing Principal Investigators with instructions on how to conduct the trials

• Collecting and authenticating data collection forms (commonly known as Case eport forms)

• Monitoring progress of clinical trials throughout the duration of the trial process

•Prepared other study materials as requested by the PI which may include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

•Established and organized study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Dianon Pathology, Shelton, CT Mar 2016 - Sept 2016

Medical Laboratory Technician (Contract Position)

•Performed routine and moderate to complex tests and analyzed according to established SOPs and GLP in designated the histology department.

•Trained in appropriately storing and handling the samples; keeping accurate records; and ensuring that the sample and its corresponding test results remain linked to the correct patient.

•Evaluated new procedures or methods under direct supervision of department supervisor or group leader.

•Worked with tissue samples from living patients or cadavers, preparing them for examination by Pathologists.

Triborough Medical Urgent Care, Brooklyn, NY Jan 2013-Dec 2015

Clinical Research Coordinator

•Helped manage drug supply through order/processing for clinical trials that involved advanced therapeutic and non therapeutic drugs.

•Collaborated with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.

•Prepared other study materials as requested by the PI which may include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.

•Established and organized study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

•Worked with Breast & Prostate Medicine Advanced Therapeutics, Cardiovascular, CNS, and Non-Therapeutic clinical trials.

•Strong knowledge in Good Clinical Practice (GCP) & EDC.

•Ensured that research protocols were approved by Institutional Review Board (IRB).

•Strong knowledge of RECIST Criteria of solid cancer tumors.

•Managed patient visits.

•Managed the data regulatory documentation for ongoing clinical trials including patients toxicity reporting.

•Assisted Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations and sponsoring agency policies and procedures.

•Assisted the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.

•Maintained documentation of training.

•Reviewed and comprehended the protocol.

•Attended investigator meetings as required or requested by the PI.

•Provided adequate information to the CRA about site visits, data, adverse events, ICF, overall process of how the lab was run.

•Helped to mentor and train newly hired research study assistants.

•Assisted with the training of staff on new aspects of the roles/responsibilities.

Unilever / Manpower, Trumbull, CT June-Sept 2013 / Jan-March 2015

Laboratory Assistant (Temp Assignments)

•Ensured the laboratory was well-stocked and resourced

•Performed laboratory tests in order to produce reliable and precise data to support scientific investigations.

•Carried out routine tasks accurately and followed strict methodologies to carry out analyses.

•Prepared specimens and samples.

•Constructed, maintained and operated standard laboratory equipment, for example centrifuges, titrators, pipetting machines and pH meters..

•Recorded and sometimes interpreted results to present to senior colleagues.

•Used computers and performing mathematical calculations for the preparation of graphs.

•Kept up to date with technical developments, especially those which could save time and improve reliability.

•Conducted searches on identified topics relevant to the research.

•Followed and ensured strict safety procedures and safety checks.

WCSU, Danbury, CT Aug 2010 - May 2011

Laboratory Assistant

•Performed laboratory tests including pre- and post-analytic phases.

•Prepared samples/specimens.

•Produced accurate and reliable data and interpret results.

•Followed methodologies in carrying routine tasks.

•Researched relevant topics and gathered information/data.

•Adhered to correct procedures, policies and health/safety guidelines.

•Kept abreast of all industry developments and best practices.

•Documented all activities, recorded results and inserted/retrieved data.

•Maintained work area and equipment.

•Provided administrative assistance.

EDUCATION

Bachelors Degree of Biology

Western Connecticut State University, Danbury, CT

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