Director of Clinical Research

Job Details

Job Location
CBO Office - Atlanta, GA

Position Type
Full Time

Education Level
4 Year Degree

Travel Percentage
As needed for business requirements.

Job Category
Ancillary Services

Description

GENERAL SUMMARY OF DUTIES: The Clinical Research Director is responsible for the daily operations and overall success of United Digestive's clinical research department. This includes oversight of central research functions, financial performance, quality assurance, and staff management across all research locations. The director ensures studies are adequately staffed, maintains and develops relationships with pharmaceutical sponsors and investigators, and supports the onboarding of new investigators. A thorough knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements is essential to this role.

REPORTS TO: Director of Ancillary Services

RESPONSIBILITIES:
Duties include but are not limited to:

• Manages overall clinical research department staff, inclusive of clinical research coordinators, clinical research nurses, and any staff performing research functions including but not limited to patient recruiters, contract / budget specialists, regulatory specialists, and business development personnel
• Oversight of both Georgia and Florida research activities for United Digestive research department, with expected travel to research sites as necessary
• Responsible for overall quality of clinical research department, including adherence to ICH-GCP, regulatory requirements, and department SOPs
• Oversees clinical research department finances working with United Digestive leadership to ensure department hits profitability targets
• Identifies, analyzes, and resolves daily workflow issues within departments including study-specific challenges
• Develops relationships with study sponsors and contract research organizations (CROs) to become a preferred site for research services on current and future studies
• Identifies, pursues, and evaluates potential new study opportunities for both profitability, viability (including proper resourcing), and alignment with investigator interest and company goals
• Maintains strong relationships with investigators at United Digestive and ensures that research staff is fully supported operationally to ensure the success of research projects
• Develop new relationships with United Digestive physicians to support the growth of the research program at United Digestive while facilitating referral program
• Encourages enrollment success by partnering with research staff and utilizing both internal and external recruitment strategies
• Supports study contracting and budgeting efforts for organizational approval, ensuring ancillary costs are covered and studies will be profitable for the department
• Works closely with UD finance team to ensure research finances are being appropriately tracked, invoiced, reconciled, and received
• Oversees the recruiting, hiring, training / development, and evaluation of all clinical research staff
• Maintains strong relationships and oversight of study sponsors throughout the entire clinical research process, including start up, ongoing monitoring visits, and close out
• Responsible for maintaining study regulatory compliance and proper site staff training including GCP, IATA, etc.
• Any other duties and special projects assigned by UD Leadership

EDUCATION, SKILLS AND EXPERIENCE:

• Required:
  
  • Bachelor's degree in healthcare or related field
  • 7+ years of clinical research experience, preferably at a clinical research site
  • Must have a strong understanding of GCP guidelines and regulatory requirements
  • Experience with clinical research CTMS platforms and workflows
  • Computer literate, ability to operate Microsoft Office applications
• Preferred:
  
  • Preferred experience with large healthcare systems
  • Preferred experience with gastrointestinal or metabolic clinical research studies

CORE SKILLS AT UNITED DIGESTIVE:
Director of Clinical Research have or must be able to:

• Plan, prioritize, and complete multiple tasks effectively
• Work under pressure; assess, respond to, and communicate issues in a timely manner
• Strong problem-solving skills and ability to handle conflict resolution
• Maintain composure and set professional examples to staff and patients
• Communicate clearly and present detailed information to a multidisciplinary audience
• Interpret and apply clinical and non-clinical policies and procedures

PHYSICAL/MENTAL/ENVIRONMENTAL DEMANDS
Requires sitting and standing associated with a normal office environment; travel as business needs require

DRUG FREE WORKPLACE
United Digestive is a drug free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.

EQUAL OPPORTUNITY EMPLOYER
United Digestive is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, gender, color or national origin in its employment practices.