Clinical Research Practitioner

Clinic Research Practitioner The Clinic Research Practitioner will provide care as well as support the daily operations and future direction of the Joslin Clinical Research Center (CRC). This individual oversees adherence to SOPs, Good Clinical Practice and FDA regulations. They are also responsible for assuring the alignment/compliance of Clinical Research Center policies and procedures with the Joslin Diabetes Center, BIDMC and BILH objectives and policies. They operate within a team-oriented environment that supports the research operation, performance improvement and staff development in clinical research. Performs Clinical Research Assessments and Procedures As needed, provide age specific care to pediatric and adult patients with or without diabetes mellitus in a collaborative practice, by using competencies in history taking, physical examination, assessment and interpretation of laboratory and related diagnostic tools for purposes of screening and safety assessments of participants participating in clinical research studies. Makes judgments relative to physical assessment and therapeutic management independently (under supervision of a licensed physician as required), using physician consultation where appropriate. Performs clinical research procedures within their scope of training and practice. Provides feedback to clinical investigators and clinical research staff on individual study projects focusing on feasibility and best practices. Works with and promotes effective communication related to problem solving and support for team members. Policies and Procedures Develops, designs, implements and monitors clinical research policies and procedures for research protocols in collaboration with the individual research teams and CRC leadership. Assists in implementation and monitoring adherence to research policies and procedures, using systems that will improve the overall operation and effectiveness of the organization. Assists in the integration/updating of research policies and procedures for external legal and administrative regulations, other regulatory agencies, research sponsors, along with the organization. Communicates changes regarding policy and procedures, practices and systems to the Clinical Research teams. Partners with BIDMC to assure any hospital policies, including pharmacy policies are adhered to and communicated to Joslin research teams. Functions on committees as needed. Performance Improvement and Education Collaborates in the development, implementation and expansion of learning opportunities and skill development for all staff. Develops and implements effective educational programs and training modules designed to assist the researchers in the progression from novice to expert in the practice of research and enhances their knowledge and guides them towards the achievement of excellence. Provides, education, training and direction to the clinical research teams to ensure safe and competent protocol execution. Contributes to educational and professional development of staff, and colleagues in an environment of mutual respect and understanding. Collaborates with the research staff at all levels, interdisciplinary team members, executive officers and other stakeholders in the development, implementation and evaluation of research programs and services to meet identified needs. Interacts with and contributes to the professional development of peers and others. Evaluates own performance based on professional practice standards, relevant studies, regulations and organizational criteria identifying areas of strength as well as areas for professional/practice development. Safety and Regulation Identifies research operation needs, helps manage equipment and supplies and monitors equipment maintenance. Assesses the environment and makes recommendations to ensure optimal patient comfort, safety and compliance with various external legal and administrative regulatory bodies. Promotes and monitors regulatory agency standards and customer service expectations for the research practice.

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