Selwyn Oruh

About Selwyn Oruh

Physician with a strong passion for clinical research, and an extensive experience of approximately half a decade handling clinical research projects phase 1 through 3 across several therapeutic areas such as Neurology, Ophthalmology, Nephrology, Oncology, Biotech and vaccine preventable diseases (COVID, CMV, RSV vaccine studies). Robust working knowledge on regulatory affairs evident by my understanding of ICH GCP guidelines and FDA regulations pertaining to clinical trials such as 21CFR part 11, 50, 54, 56 312 and 314. Proficient in clinical trial management systems (Clinical conductor, Realtime), Microsoft applications (Excel, Word and PowerPoint), Interactive Response Technology (IRT) such as (SUVODA and Endpoint) and other electronic data capture (EDC) tools (Inform, Medidata rave). Furthermore, my medical background strengthens my understanding of the investigational product (IP) and quick recognition of possible AEs and SAEs. My skill set is strongly complemented by my effective communication skills, well demonstrated by my successful track record dealing with pertinent stakeholders, investigators, coordinators, monitors, sponsors, IRB, FDA and above all the research subject.

Experience

1. Clinical Research Coordinator

   Tekton Research

   Sep 2023 — Present · Yukon, OK, US

   Participated in site initiation visits (SIV)- Obtained informed consent from participating subjects-Conducted screening, randomization, follow-up, illness and telephone visits- Reviewed patient ediary entries and documented payment once completed-Resolved study EDC queries in a timely manner-Organized, prepared and shipped study related specimens-Conducted clinical research studies such as Influenza, CMV, EBV, in accordance with study protocol and in conjunction with GCP and ICH guidelines-Managed study related compliance documents and ensured that regulatory standards were met on time-Maintained a delegation of authority and training log for each study-Managed patient progression through protocoled study visits and maintained sponsor engagement on critical events such as changes in patient medical history and concomitant medications that may exclude the patient from the study-Identified and reported AEs/SAEs in accordance with study protocol-Assisted the unblinded pharmacist as back up-Participated in community outreach efforts to educate and recruit potential participants and physicians-Provided support and guidance during audits and inspections.

Education

• Windsor University School of Medicine

  Doctor of Medicine - MD

  2008 — 2012