・Responsible for hiring, training and retaining qualified CRAs and resource allocation to study teams. Accountable for the performance the CRAs and assures that quality of services meets internal and external customer requirements. The CRA Manager must also exercise judgment in planning and organizing work; monitor performance and report status, sets goals, and ensure that they are met while being
responsible for continuous process improvement.
・Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development.
・Accountable for the development of direct reports through performance reviews, instruction, mentoring, and coaching.
・Accountable for the performance and work output of direct reports. Sets goals which align with study team goals.
・Assigns appropriate clinical personnel to clinical studies.
・Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, ethical behavior, favorable community image, and actualization of the SJM Core Values.
・Contributes to global process improvement teams.
・Utilize the CRA Activity Dashboard to track CRA work output.
・Ensure new hires are trained in SJM policies and procedures, Clinical Data Systems, Clinical Process/Procedures and Study specific topics.
・Ensure that CRAs are updated and advised on new or changed processes,
procedures, and policies.
・Maintain positive and cooperative communications and collaboration with all levels of employees, customers, and contractors.
・Develops an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies.
・Provides input to departmental Standard Operating Procedures (SOPs) and
Departmental Work Instruction (DWIs).
・A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
・Minimum seven years clinical research experience.
・Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills. Able to meet deadlines and work effectively with all levels of employees.
・Proficiency in Microsoft Office Suite and relevant clinical applications.
・The ability to work independently when necessary.
・Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field.
・An excellent understanding of all aspects of clinical research. A general familiarity with cardiac, vascular, and/or neuromodulation technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
・Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).