Director of Research

Description

The Director of Clinical Research will provide oversight, leadership, and guidance in the management and execution of clinical research at Atlanta Diabetes Associates. Will help to develop and maintain relationships with clients, develop and support staff, and oversee the day-to-day operations of the research department.

JOB CLASSIFICATION

Salaried Exempt

Tasks:

• Develop operating procedures and ensure that the entire research team follows those procedures. Evaluate new operational methodologies that would increase efficiencies, provide a competitive advantage, and reduce costs.
• Ensure that all federal and state regulations are followed completely.
• Handle HR roles alongside HR Department, including overseeing the hiring and employee management processes. Develop succession and training plans for all direct reports and conduct annual performance reviews.
• Select, coach, counsel, and develop all site staff to ensure they possess the necessary knowledge and skills to achieve operational and revenue objectives.
• Conduct monthly site meetings to communicate information, provide continuing education, training, and enhance teamwork.
• Ensure the site is maintained in an attractive, safe, and efficient manner.
• Maintain comprehensive knowledge of all protocols being conducted.
• Perform quality reviews to ensure the adequate execution of protocols and ensure adequate site staff training as needed.
• Assist with the development and implementation of corrective and preventive actions to maintain a high-quality site.
• Provide leadership and manage the study recruitment to ensure enrollment goals are met or exceeded.
• Direct and guide site staff on study-specific tasks; assist in training staff.
• Establish rapport with sponsor representatives and maintain frequent face-to-face, written, and telephone contact with various persons involved in the study, including but not limited to the patients, relatives/friends of the patients, doctors, pharmaceutical sponsors, and all levels of the company
• Ensure the completion and timely return of feasibility and site qualification questionnaires to the Pharmaceutical Companies/CROs
• Administrative oversight of all regulatory aspects of trials
• Review and completion of NDAs and study contracts
• Participate in the design, development, and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research-related documents and study reports
• Oversee invoicing and confirm payment of study expenses, such as IRB fees, vendor fees, and study subject payments
• Investigator-initiated study protocols

Skills and Qualifications:

• High personal motivation, self-management, and detail orientation; ability to take responsibility for meeting deadlines and making progress without direct supervision.
• Strong spoken and written communication skills.
• Capacity and willingness to learn new software, research methods, and work routines quickly; flexibility in responding to new research opportunities as they arise.
• Technologically savvy and able to learn new programs quickly and able to troubleshoot common issues; proficiency in Word, Excel, PowerPoint, Outlook, and Internet skills
• Articulate and tactful communication skills; readiness to meet and work directly with clients.
• Experience managing people and projects; must be able to handle multiple projects and changing priorities.
• Possess a high level of self-confidence and demonstrate the ability to take initiative.
• Have excellent attention to detail and high-level accuracy with documents
• Ability to assess, prioritize and act quickly
• Learning-based and solution-oriented
• Deadline driven and extremely organized
• Ability to maintain the goodwill and reputation of the entire team

Supervision:

Work is performed under general supervision from the Principal Investor for study-specific items

with indirect reporting to the Practice Manager for administrative assistance.

Equipment:

Must be familiar with scientific and medical equipment used in the particular field of laboratory,

medical, and clinical research.

Working Conditions:

Work is predominately performed in an office, laboratory, and/or clinic environment, with

occasional work from home.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Management retains the right to add or change the duties of the position at any time.

Requirements

EDUCATION:

Required

Bachelor's degree in Life Sciences, Healthcare Administration, Nursing, Public Health, or related

field.

Minimum 7 years of clinical research experience.

Minimum 3 years of leadership or management experience within 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.

Preferred

Advanced clinical credentials preferred, including Nurse Practitioner (NP), Physician Assistant (PA), PharmD, or other advanced healthcare professional designation.

Master's degree in Healthcare Administration, Public Health, Business Administration, or related field accepted.

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.

IMPORTANT:

Any qualifications to be considered as equivalents in lieu of stated minimums require prior approval of the Division Manager, Principal Investigator, and Chief Operations Officer. Information resources, including data, information, technology, and software, are Atlanta Diabetes Associates' resources and must be protected and used in conformance with all applicable laws and policies in accordance with Information Security Standards.