Explore an exciting opportunity as a GForce Life Sciences in United States, . This Part-time role is ideal for professionals interested in the Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research sector and offers hands-on experience in the Research, Science, and Project Management department .
Rated 4.1/5 by employees, this opening is perfect for candidates at the Mid-Senior level Level Job. Posted 12 hours ago, and still accepting applications — don’t miss out.
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“GForce Life Sciences” Company Job Details
- Company Name: GForce Life Sciences
- Work Type: Part-time
- Rating: 4.1 / 5
- Location: United States,
- Industry: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
- Department: Research, Science, and Project Management
- Experience Level: Mid-Senior level
- Job Creation Duration: 12 hours ago
Clinical Research Associate, Medical Device Job Details | Part Time Jobs in United States
Consultant, Clinical Site Lead, Medical Devices
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. 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
- 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
- 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.
- 3-5+ years of clinical trial monitoring experience required.
- 5-8+ years of experience with medical device clinical trials.
- Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment.
Term & Start
- Remote/home-based; Ideally located in Illinois, North Dakota, South Dakota, Minnesota, Iowa, Nebraska, Wisconsin, Kansas, or Missouri
- 50-75% travel (depending on clinical trials)
- 12-month contract (extension probable)
- Part-time: 20-30hrs/week
