Candette Buckingham, CCRP

Founder, President and Principal/Lead/Senior Clinical Research Associate

Over 14 years clinical research experience as a Co-Clinical Study Lead, Clinical Research Associate and Coordinator. For the past 9 years functioning as a Co-Clinical Study Lead (CTM), Principal CRA, Lead CRA, Senior CRA, and CRA with sponsor and CRO companies and can travel without limits. Recently completed three Certification Trainings for CPM, one with SoCRA, Barnett International and MAGI and one Certification for Clinical Research Auditing with Barnett International, also studying PMBOK Guide Fifth Edition avidly.

As the Co-Clinical Study Lead (CTM) responsibilities range from managing vendors (ClinCard system, Lab Vendors and Ancillary Supplies), reviewing Trip Reports, writing Newsletters sent to Investigator sites, reviewing AE, SAE, PD, Query and ET reports monthly. In addition, have responsibilities for editing Annotated Trip Reports, CMP and Source Documentation Worksheets, and training CRAs for IP return. Prepared data for DBL, managed PDs for rankings (major/minor), reviewed the eTMF for Inspection Readiness and archiving. Subject Matter Expert (SME) for our SOPs on PDs, CRA Oversight and Unblinding. Member of the CDR Working Group and assisted in the creation of the CDR Plan template.
As the Principal CRA, I was in charge of CRO Oversight for the United States, Canada and LATAM for a Switzerland based pharmaceutical. Prior to becoming a CRA, was a proud CRC for five years and Certified CCRP through the SoCRA organization.

Extensive knowledge of conducting Drug and Device Clinical Trials, phase 1, 2, 3 and 4 in Multi-Specialties including; Oncology, Cardiology, Urology, and Otolaryngology with the following indications; Prostate Cancer, Sarcoma, Bladder Cancer, DES (Drug Eluting Stents), Heart Pump, DAPT (Dual Antiplatelet Therapy), Stent Thrombosis, Optimization after Cardiac Resynchronization Therapy Device Replacement, OAB (Over Active Bladder), Peyronie’s Disease, LUTS (Lower Urinary Tract Symptoms), Urinary Incontinence, Urinary Retention, Nocturia, MS (Multiple Sclerosis), PSA (Prostate Specific Antigen), Spermatogenesis, BPH (Benign Prostatic Hyperplasia), ED (Erectile Dysfunction), Meniere’s disease, Chronic Prostatitis, Crohn's, Glaucoma, Endometriosis, Cystic Fibrosis, Skin Irritation, and Sensitization Potential of a Vehicle Patch and HPV Lab Assay Device. 

I decided to become a consultant/contractor for Clinical Operations and therefor founded Quality Research Consulting (QRC)