TITLE: Director of Clinical Research
LOCATION: San Diego, CA
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective for the Director of Clinical Research is to lead the day-to-day affairs of an established dermatology clinical research group; direct the patient/subject recruitment and eligibility determination to promote good clinical practices (GCP) in the conduct of clinical investigations by possessing knowledge of Food and Drug Administration (FDA) regulations and human subject protection; and lead and perform patient care, adverse event reporting, and all other study-related activities.
EDUCATION AND EXPERIENCE:
- M.D. degree required, with current licensure in the state of California, or a license in at least one U.S. state that can lead to licensure in California.
- Board certification in Dermatology (or Board Eligibility).
- At least five years clinical research experience following completion of residency preferred.
- Some management experience preferred.
- Experience interacting with the FDA preferred but not essential.
- Ability to conduct studies in accordance with established GCPs as defined by the FDA, within the Standard Operating Procedures (SOPs) and the TCR Administrative Policies.
- Possess working knowledge of prevention, etiology, therapies and new research developments.
- Excellent written and verbal communication skills, as evidenced by a record of publications and public speaking.
MAJOR RESPONSIBILITIES AND DUTIES:
- Consistently exhibit behavior and communication skills that demonstrate a commitment to superior customer service, including quality care and concern, with every internal and external customer.
- Responsible for the management of the clinical research group and for providing leadership and clinical supervision of staff members with respect to clinic activities, coordinating duties etc.
- Serve as the Principal Investigator or Sub-Investigator on clinical trials.
- Perform clinical duties in conjunction with a multidisciplinary clinical team to execute research trials in accordance with study protocols and provide optimal and appropriate health care to patients in research studies.
- Attend Investigator Meetings as required and participate in meetings/conferences related to study protocols and research.
- Evaluate protocols and budgets for new clinical study opportunities; make recommendations to accept or reject studies based on the organizations capabilities and resources.
- Ensure compliance with applicable licensure/certification requirements, applicable healthcare standards and government laws and regulations, as well as policies and procedures.
- Maintain knowledge base as to developments and trends in medical sciences.
- 2 years ago - save job