Duration: 12 month contract with the possibility for extension
Job Duties: • Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. • Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include, but is not limited to:
o Reviewing data and source documentation from investigational sites for accuracy and completeness
o Ensuring adverse events and protocol deviations are reported in an efficient manner
o Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
o Resolving and/or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence • Coordinates with study teams, field clinical engineers or designee and specialists to:
o Enroll sites into new and ongoing clinical studies
o Facilitate enrollment of study subjects via site coordinators
o Facilitate resolution of data queries and action items at clinical sites • Promptly reports the findings of monitoring visits according to SJM processes. • Collaborates with in-house teams to ensure complete submission of study documents. • Participates in conference calls and training sessions. • Trains site personnel to ensure compliance with the study protocol and local regulations. • Mentors less experienced clinical team members as requested. • Demonstrates a high level of written and verbal communication skills with internal and external customers.
Minimum Qualifications: • A Bachelor's degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field. • Superb understanding of all aspects of clinical research. • Minimum five years clinical research experience. • Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills. • Ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees. • Basic personal computer skills including a working familiarity with word processing software and relevant clinical applications. • The ability to work independently and function within a dynamic, global team environment. • The ability to exchange straightforward information, ask questions, and check for understanding.
Preferred Qualifications: • Strong preference for prior clinical monitoring experience. • A general familiarity with cardiac, vascular, and/or neuromodulation technologies. • Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment. • Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution