Job Number: 414840
Clinical Research Associates
The Research Associate - Registries and Clinical Studies is responsible for planning and implementing clinical/patient data registries and related studies to support health services and outcomes research and quality projects for the American Society of Plastic Surgeons (ASPS) and The Plastic Surgery Foundation (PSF). This position serves as the organization liaison between registry/study physician leadership and ASPS/PSF staff, partners, contractors and study sites. The incumbent is responsible for managing all components related to facilitating, designing and executing ASPS/PSF initiated registries and clinical studies/trials including, 1) appropriate documentation (including regulatory) and contracting, 2) study design and case report form development, 3) grant and manuscript writing, 4) study implementation, execution and management, and 5) project close-out.
Education: Bachelor's degree in science or health related field. Masters degree in health services research, epidemiology, public health, biomedical science or health profession preferred.
Experience: A minimum of 2 years of experience in clinical research involving patient registries and health services and outcomes research. Demonstrated knowledge and practical experience working with registries and study design, protocol development and implementation, clinical data management required. Experience with multi-center studies, study site identification, recruitment and monitoring, IRB applications and budget management preferred.
Demonstrated experience in research grant writing, knowledge of scientific research methodology, familiarity with medical/scientific terminology and knowledge of NIH and extramural funding agencies. Scientific publication record, preferred.
Practical knowledge and skills knowledge of clinical research procedures, regulatory guidelines, and clinical project management.
Demonstrated experience in successful project leadership. Ability to manage multiple projects simultaneously and to prioritize work and handle diverse responsibilities.
Experience in monitoring clinical studies.
Knowledge of HIPAA and other regulatory issues regarding the conduct of human research.
Experience in conducting critical appraisals of scientific literature.
Attributes: Excellent interpersonal and public speaking skills.
Ability to work well independently as well as work and interact with cross-functional teams.
Ability to think ahead and plan over a three-year time span.
Able to use discretion and maintain confidentiality.