Lead, Clinical Research

Job Purpose

The Lead, Clinical Research is responsible for the overall coordination of the clinical trial start up process (feasibility and implementation) and conduct of both Therapeutic Development Network and pharmaceutical sponsored CF clinical studies, coordination and implementation of clinical research education, and policy development at the Baylor Pediatrics-Pulmonary department. This position will leads the research team and works with the team to identify/mitigate/escalate study issues and ensures solutions are implemented. The Lead, Clinical Research will also lead the research team in QI projects as required by the Cystic Fibrosis Therapeutics Development Network or other entity.

Job Duties

• Coaches, reviews and delegates work to lower level professionals, including managing the day-to-day activities of the research coordinators, in setting expectations, providing training, managing timelines and deliverables.
• Leads the research and QI meetings including minutes preparation and project tracking.
• Leads the education of clinical research of all current and onboarding team members and provide guidance during their orientation and employment.
• Develops systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
• Tracks study metrics within the Cystic Fibrosis Therapeutics Development Network system.
• Oversee Standard of Operations development and continual updates.
• Manages project deliverables and ensures they meet division expectations and timelines. Responsible for the preparation and submits of regulatory compliance documents for new studies.
• Serves as the primary contact with the Section faculty and staff members for clinical research projects.
• Develops all research policy, procedures and regulatory communications for section faculty and staff members.
• Responsible for the financial management of the clinical studies, including developing cost analysis, budget planning and resource allocation. Also responsible for negotiating budgets with research sponsors.
• Ensures all research team members are compliant with all aspects of GCP and tracking of GCP training.
• Contributes to the development of goals for the research team.

Minimum Qualifications

• Bachelor's degree.
• Six years of relevant experience.

Preferred Qualifications

• Familiarity with EPIC/EMR.
• Working knowledge of central and local IRBs such as WIRB, Advarra etc.
• Previously worked with a pediatric experience.
• CCRC, CCRP, and/or SOCRA certified.

Other

• Direct experience in clinical research.
• Project management experience and techniques.
• Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer.
• Effective verbal and writing skills at all level including to senior leadership; prior experience with oral presentation.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5415

CA; CH