Director of Research

ATLANTA DIABETES ASSOCIATES PC•Atlanta, GA

About The Position

The Director of Clinical Research provides oversight, leadership, and guidance in managing and executing clinical research at Atlanta Diabetes Associates. The role develops and maintains client relationships, supports and develops staff, and oversees the research department’s day-to-day operations. It is salaried exempt and works under general supervision from the Principal Investigator for study-specific matters, with indirect reporting to the Practice Manager for administrative assistance. The Director develops and maintains operating procedures, ensures regulatory compliance, manages and trains staff, supports study recruitment and enrollment, and oversees research quality and trial operations. The role also contributes to clinical research documents and protocols, administers regulatory matters, maintains sponsor relationships, and oversees study-related invoicing and payments. Work is predominantly in an office, laboratory, and/or clinic, with occasional work from home. Management may add or change duties; the listed responsibilities are not exhaustive.

Requirements

Bachelor’s degree in Life Sciences, Healthcare Administration, Nursing, Public Health, or a related field.
At least 7 years of clinical research experience.
At least 3 years of leadership or management experience in a clinical research setting.
Strong knowledge of FDA regulations, ICH-GCP guidelines, IRB processes, and clinical trial operations.
Experience managing research budgets, contracts, and sponsor relationships.
Demonstrated success leading multidisciplinary teams.
High personal motivation, self-management, and attention to detail; ability to meet deadlines and make progress without direct supervision.
Strong spoken and written communication skills; articulate and tactful communication and readiness to work directly with clients.
Ability to learn new software, research methods, and work routines quickly, and flexibility in responding to new research opportunities.
Technological proficiency, including the ability to learn programs and troubleshoot common issues; proficiency in Word, Excel, PowerPoint, Outlook, and internet skills.
Experience managing people and projects, including handling multiple projects and changing priorities.
Self-confidence and ability to take initiative.
Excellent attention to detail and accuracy with documents.
Ability to assess, prioritize, and act quickly.
Learning-based and solution-oriented approach; deadline-driven and highly organized.
Ability to maintain the goodwill and reputation of the team.
Familiarity with scientific and medical equipment used in laboratory, medical, and clinical research.
Any qualifications proposed as equivalents to stated minimums require prior approval from the Division Manager, Principal Investigator, and Chief Operations Officer.

Nice To Haves

Advanced clinical credentials, such as Nurse Practitioner (NP), Physician Assistant (PA), PharmD, or another advanced healthcare professional designation.
Master’s degree in Healthcare Administration, Public Health, Business Administration, or a related field.
CCRP, CCRC, CIP, or equivalent clinical research certification.
Experience in endocrinology, diabetes, metabolic disease, or other specialty research programs.
Experience with multi-site clinical research operations.
Knowledge of clinical trial management systems (CTMS) and electronic regulatory platforms.

Responsibilities

Develop operating procedures, ensure the research team follows them, and evaluate operational methods to improve efficiency, competitiveness, and cost management.
Ensure compliance with all federal and state regulations.
Handle human resources responsibilities alongside the HR Department, including hiring and employee management; develop succession and training plans for direct reports and conduct annual performance reviews.
Select, coach, counsel, and develop site staff to support operational and revenue objectives.
Conduct monthly site meetings to communicate information, provide continuing education and training, and enhance teamwork.
Ensure the site is maintained in an attractive, safe, and efficient manner.
Maintain comprehensive knowledge of all active study protocols.
Conduct quality reviews to assess protocol execution and identify staff training needs.
Assist with developing and implementing corrective and preventive actions to maintain site quality.
Lead and manage study recruitment to meet or exceed enrollment goals.
Direct and guide site staff on study-specific tasks and assist with staff training.
Build rapport with sponsor representatives and maintain frequent in-person, written, and telephone contact with people involved in studies, including patients, their relatives or friends, doctors, pharmaceutical sponsors, and company personnel.
Ensure feasibility and site qualification questionnaires are completed and returned on time to pharmaceutical companies and CROs.
Provide administrative oversight of trial regulatory matters.
Review and complete NDAs and study contracts.
Participate in the design, development, and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, other clinical research documents, and study reports.
Oversee invoicing and confirm payment of study expenses, including IRB fees, vendor fees, and study subject payments.
Work on investigator-initiated study protocols.
Protect and use Atlanta Diabetes Associates information resources, including data, information, technology, and software, in accordance with applicable laws, policies, and Information Security Standards.