Clinical Site Lead

GForce Life Sciences; California; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k

Job summary

Fortune 500 Medical Device Company is seeking a Clinical Site Lead (CSL) to oversee site maintenance, data collection, and field monitoring in accordance with study protocols and regulatory requirements. The CSL will manage essential documents, resolve data discrepancies, review adverse events, and coordinate site initiation.

The role requires strong analytical problem-solving skills, process optimization, and continuous quality improvement, with travel to West Coast sites as needed.

Qualifications

• Bachelor’s degree in natural science, pre-medicine, nursing, bioengineering, or related field.
• 10+ years of clinical trial monitoring experience.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Experience in medical device/pharma settings or clinical environments.

Responsibilities

• Monitor studies at assigned sites to ensure GCP compliance and accurate data collection.
• Review data and source documentation for accuracy.
• Ensure adverse events and protocol deviations are reported promptly.
• Coordinate site initiation, monitoring, and close-out visits.
• Ensure device complaints and malfunctions are reported per policies.

Skills

Regulatory compliance

Clinical monitoring

Quality improvement

Analytical problem-solving

Site coordination

Education

Bachelor’s Degree in natural science or related field

Tools

SoCRA/ACRP certification

Job description

Our client, a Fortune 500 Medical Device company, has engaged GForce Life Sciences to source a skilled Clinical Site Lead (CSL). The CSL will oversee clinical study site maintenance, data collection, and field monitoring to ensure compliance with protocols, regulations, and Good Clinical Practices. Responsibilities include managing essential documents, resolving data discrepancies, reviewing adverse events, and coordinating site initiation. The role requires analytical problem-solving, process optimization, and continuous quality improvement. The CSL will monitor site performance, identify areas for improvement, and provide 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.
• 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 the client’s 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.
• 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 the client’s processes.
• Collaborates with in-house teams to ensure complete submission of study documents.
• Trains site personnel to ensure compliance with the study protocol and local regulations.

Requirements

• Bachelor’s Degree - Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• 10+ years of clinical trial monitoring experience required.
• 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.

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 with travel to sites on the west coast
• Must be located in a metropolitan city on the West Coast (Los Angeles, San Diego, Phoenix, Seattle, etc.)?
• 50-75% travel (depending on clinical trials)
• Benefits available (Medical, Dental, Vision, 401k)