Edwin Clark

Background

About Edwin Clark

Results-driven SCRA II with experience overseeing and managing all phases of clinical trials for both drug and medical device studies. Skilled in conducting site selection and initiation visits, monitoring site activities for protocol adherence, providing day-to-day study management and site support, and ensuring data integrity and regulatory compliance. Demonstrated strong leadership capabilities by effectively leading and mentoring a team of CRAs, building strong relationships with investigators, sponsors, site coordinators, and cross-functional teams, fostering collaboration to achieve study objectives within strict timelines and allocated resources. THERAPEUTIC AREAS Infectious Disease & Vaccines: COVID-19, Flu, HPV, HIV Oncology: Non-Hodgkin Lymphoma, Leukemia, Breast Cancer, Lung Cancer, Cervical Cancer Neurology: Alzheimer’s disease, Pain Medical Devices: Inhalers, Heart Valves, Stents, Orthopedics Metabolic: Diabetes, Obesity Cardiovascular: Hypertension, HF, AF Ophthalmology: Glaucoma, Diabetic Retinopathy, Cataract SKILLS & CORE COMPETENCES Good understanding of FDA regulations and ICH/GCP guidelines governing clinical trials. Ability to contribute to the development of clinical protocols, informed consent forms, and case report forms. Ability to manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Solid problem-solving skills with ability to identify, assess and resolve site performance, quality or compliance problems. Exceptional interpersonal skills to develop strong site relationships through all phases of the trial. Excellent verbal and written communication skills. Highly organized with ability to manage multiple projects simultaneously while maintaining quality, timelines and ensuring prioritization of subjects’ safety. Proficient in clinical data management tools (Oracle, Medidata RAVE), statistical analysis software (SAS, R), Microsoft Office (Word, Excel, PowerPoint), MS Project, and Basecamp.