Clinical Site Lead

Job Duties

• Maintains clinical study site maintenance, data and source documentation collection.
• Ensures compliance to the study protocol, and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures.
• Solves a range of straightforward and complex problems and analyzes possible solutions using standard procedures.
• Identifies and obtains missing data, data corrections, reviews adverse events and protocol deviations.
• Maintains accurate, detailed and complete records of monitoring visits.
• Coordinates the initiation of the clinical site with the assigned Field Clinical Engineer or designer and/or appropriate in-house personnel.
• 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.
• Reviews data and source documentation from investigational sites for accuracy and completeness.
• Ensures adverse events and protocol deviations are reported in an efficient manner.
• Ensures that device complaints and malfunctions are reported according to SJM Policies and Procedures.
• Resolves and/or facilitates resolution of problems including identification of cause and actions to prevent reoccurrence.
• Coordinates with study teams, field clinical engineers or designee and specialists to: enroll sites into new and ongoing clinical studies, facilitate enrollment of study subjects via site coordinators, 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.

Requirements

• 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.
• 10 years of experience in clinical research monitoring.
• Ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees.
• Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.

Preferred Qualifications

• A general familiarity with cardiac, vascular, and/or neuromodulation technologies.
• 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).

Term & Start: Remote; Ideally located in Phoenix, AZ
50-75% travel (depending on clinical trials)
12-month contract (extension probable)

Benefits

• Medical
• Dental
• Vision
• 401k

Pay

65-70/hr