Clinical Research Director (Office - Based Winston-Salem ) - NCR
Novella Clinical is looking for a Clinical Research Director specializing in multiple therapeutics located in Winston- Salem, NC
The employee’s Number One job responsibility is to deliver the most remarkable patient experience, in every dimension, every time, and understand how he or she contributes to the health system’s vision of achieving that commitment to patients and families. Responsible for the organization, management, and operations for clinical research. Through leadership and oversight will assist in development of integrated regulatory/quality assurance process, policies and procedures, budgets/contracts as well as growth and strategic planning.
Education: Bachelor’s Degree in clinical research, biology, or related field- Required
Experience: Minimum 5 years work experience in research supervisory/management roles.
Licensure/Certification/Registration: CCRP or CCRC – Preferred
Additional Skills Required:
Extensive working knowledge of research processes as they relate to pharmaceutically and NCI sponsored research. Excellent interpersonal skills with proven written, presentation and verbal competencies; excellent telephone diplomacy. Working knowledge of Microsoft Office (word processing, computer spreadsheets, mainframe computer applications) and database management. Knowledge of medical terminology and regulatory compliance according to NIH, OHRP and FDA. Organizational skills to manage multiple priorities and timelines. Attention to detail and accuracy necessary. Acute awareness of confidentiality of information. Demonstrates teamwork and cooperation
in department goals and objectives. Self-motivated and able to work independently as well as a team. Must provide own transportation to clinics, hospitals, and agencies as required. Knowledge and
assessment skills to provide age appropriate care and protocol requirement.
Additional Skills Preferred:
Bachelor’s degree in clinical research, biology, or related field.
1. Regulatory and Quality Assurance: Actively engages in the support of personnel dedicated to quality assurance. Promotes and develops structure for continuous readiness for audits. Responsible for overseeing the regulatory processes to ensure compliance with appropriate regulatory authorities including FDA, OHRP, IRB (both local and central), NCI and sponsors. Assures compliance with GCP and ICH guidelines as applicable.
2. Policies and Procedures: Collaborate with managers to review local processes and policies to ensure uniformity. Periodically reviews processes including SOPs and departmental processes to ensure
compliance within current guidelines. Develops and maintains programs and processes related to specific needs of the successful conduct of clinical research.
3. Budget and Contract: Collaborate with study sponsors to achieve an approved budget following Company policy. Partner with Legal to achieve an approved contract following all of the applicable legal guidelines.
4. Development and Growth: Develop and foster physician relations across all markets. Work with the Research committee to ensure goals of developed in conjunction with company’s mission, vision and values. Develop and maintain strategic partnerships with pharmaceutical sponsors.
55. Mission, Vision and Values: Uses interpersonal communication skills to achieve acceptable
outcomes. Demonstrates consistent behavior in support of the organizational mission, vision, and values when dealing with study participants, families, peers, colleagues, and all customers.
Demonstrates behaviors that reflect quality, professionalism, teamwork, and excellence. Demonstrates effective and efficient decision making capabilities daily and adjusts decisions to meet organizational
6. Professional Competency: Follows and supports OSHA, HIPAA, and JCAHO regulations. Uses appropriate infection control modalities when required. Demonstrates and supports excellent customer
service behavior. Complies with organizational and office attendance policies. Complies with and maintains annual mandatory training and health screening. Maintains professional credentials with
appropriate continuing education activities.
685All other duties as assigned.
EEO Minorities/Females/Protected Veterans/Disabled
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