Research Clinic Manager

Location
San Diego, California
Posted
Feb 15, 2018
Required Education
Bachelors Degree
Position Type
Full time

The primary duty for the Research Clinic Manager is to lead the day-to-day operations and manage the staff of an established clinical research and private practice dermatology group. To do this the Research Clinic Manager performs a variety of activities including, but not limited to:

  • 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 private practice clinic activities.
  • Providing leadership and clinical supervision of staff members with respect to research and clinic activities, coordinating duties etc.
  • 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.
  • Lead study start-up activities, SIVs (Site Initiation Visits), audits etc.
  • 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 clinical research study execution.
  • Oversee updating and maintenance of the electronic patient database.
  • Develop thorough understanding of the database functionality and serve as resource to other users
  • Maintain training records for team members and manage updates to training modules in line with industry and regulatory guidance and requirements.
  • Attend and lead weekly staff meetings and review protocol updates, training updates or other items as necessary
  • Work with Contracts and Finance Contacts as well as Regulatory Associate to ensure all study start up materials are submitted in a timely manner to applicable sponsors and/or regulatory agencies
  • Meet/speak with the Sponsor representatives and serve as point of contact to discuss study logistics, start-up activities, budgets, etc.
  • Supervise and Manage Compliance and training programs such as OSHA, HIPAA, other in house trainings, etc.
  • Have a working knowledge of all sponsors’ protocols
  • Serve as back up or study support staff to study coordinators and front desk staff when needed.

Qualifications:

  • Bachelor's Degree (Science or Medical-related).
  • At least five years clinical research experience with a strong understanding of GCP, ICH guidelines.
  • Minimum three years management experience.
  • Advanced Degree a plus.