Clinical Site Lead

GForce Life Sciences; Dallas (TX); Remote; USD 68,880 - 103,320; Part time

Job summary

An established industry player in the medical device sector is seeking a Clinical Site Lead to oversee clinical studies and ensure compliance with regulations. In this pivotal role, you will manage site performance, resolve data discrepancies, and facilitate the enrollment of study subjects. Your expertise in clinical trial monitoring and problem-solving will help optimize processes and improve quality. With a focus on collaboration, you will work closely with site personnel and study teams to ensure successful project execution. This opportunity offers a part-time, remote position with travel requirements, making it an ideal fit for experienced professionals looking to make a significant impact in the field.

Qualifications

• 10+ years of clinical trial monitoring experience required.
• Certification by an industry-recognized professional society is preferred.

Responsibilities

• Oversee clinical study site maintenance and ensure compliance with protocols.
• Review data and source documentation for accuracy and completeness.
• Train site personnel to ensure compliance with study protocols.

Skills

Analytical problem-solving

Process optimization

Quality improvement

Clinical trial monitoring

Data collection

Regulatory compliance

Education

Bachelor’s Degree in natural science, pre-medicine, nursing, or bioengineering

Tools

Clinical trial management software

Job description

3 days ago Be among the first 25 applicants

This range is provided by GForce Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $75.00/hr

Summary

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.
• Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP) or accredited institution).

Term & Start

• Remote/home-based; Ideally located in Dallas, TX, Minneapolis, MN, or Chicago, IL.
• 50-75% travel (depending on clinical trials).
• Part-time: 25-30hrs/week.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Research and Science

Industries

• Biotechnology Research, Research Services, and Medical Equipment Manufacturing