Tiffany M. Harding, CCRC, MSCS, CPT Clinical Research Manager
Director of Clinical Research Professional, qualified by over 20 years of visible achievements in clinical research, with concentrations in CNS clinical trials. Combine resourcefulness and problem-solving skills with clinical knowledge and analytical thinking to consistently deliver improved research and production results. Team player dedicated to quality and bottom-line objectives.
- Knowledge in all areas of research including budgeting and clinical trial agreements (CTA), GCP and FDA guidelines, IRB protocol submissions, ongoing and close-out regulatory requirements, and IND safety reporting.
- Demonstrated competencies in managing clinical trials data, formulating source documents, formulating site SOP documents, CRF completion, adverse event and serious adverse event reporting.
- Proven project management abilities with capacity to design, plan and implement ideas from conception through completion; able to manage multiple responsibilities without compromise to detail or quality.
- Outstanding interpersonal skills; equally comfortable communicating one-on-one or addressing large audiences. Solid ability to translate medical information and provide training to staff, physicians, and patients.
- Committed quality patient care; frequently recognized by physicians for strict attention to detail, patient advocacy and decision-making abilities in critical situations.
- Complete all patient aspects of clinical trial visits; perform screening visits, follow-up visits and end of study/completion visits.
- Perform both virtual and on-site monitoring visits with sponsoring companies with attention to detail.
- In addition to clinical trial management, oversee all aspects of the Intrathecal Baclofen Pump Program (for spasticity management in MS, TBI and CP) including reprogramming dosages, assisting in sterilized refill procedures and coordinating all replacements with a qualified neurosurgical practice.
- Worked both in-person and virtually during the COVD-19 pandemic to provide quality patient care and ensure quality research initiatives.