Clinical Site Lead

Summary

Our client, a Fortune 500 medical device Company, has engaged GForce Life Sciences to provide an experienced, high caliber Clinical Site Lead. Working with a minimal level of remote guidance and direction, is accountable for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials. 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. Able to solve a range of straightforward and complex problems and analyze possible solutions using standard procedures. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing adverse events and protocol deviations. Maintains accurate, detailed and complete records of monitoring visits. In consultation with the assigned Field Clinical Engineer or designer and/or appropriate in-house personnel, coordinates the initiation of the clinical site. Work requires the application of theoretical principles and creative/analytical techniques. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Stays abreast of and consults on technical advancements. Promotes the process of continuous quality improvement and risk management, and coordinates solutions for technical and project issues. Exercises judgment in planning and organizing work; monitors performance and reports status. Identifies areas of process improvement and provides solutions to Management. 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:
• Reviewing data and source documentation from investigational sites for accuracy and completeness
• Ensuring adverse events and protocol deviations are reported in an efficient manner
• Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
• 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:
• 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; must be located in CA
• 50-75% travel (depending on clinical trials)
• Part-time: 20-30 hours/week
• 12-month contract (extension probable)
• Benefits available (Medical, Dental, Vision, 401k)

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