Source Job

• Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
• Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
• Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.

Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.

• Provide operational oversight and support for multiple clinical research sites within the network.
• Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
• Build and maintain strong working relationships with Sponsors, CROs, and external partners.

Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.

• Oversees all aspects of study site management to ensure patient safety and data quality.
• Independently conducts all forms of site visits and prepares monitoring reports.
• Communicates effectively with site personnel and Precision Project and Clinical Trial Management.

Precision Medicine Group is a company that works in clinical research. They are an equal opportunity employer that values diversity and inclusion.

• Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
• Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
• Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.

Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.

• Supports all phases of clinical development and execution.
• Ensures high quality data by being the study protocol expert and key site resource for questions.
• Maintains and tracks clinical study data and supports investigator qualification selection.

SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.

• Reviews patient data for Phase I-IV clinical research and non-interventional studies to ensure compliance with protocols and regulatory requirements.
• Communicates and escalates serious issues to the project team and develops action plans as needed.
• Maintains working knowledge of ICH/GCP guidelines and company SOPs, documenting activities per project requirements.

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are a global company with over 29,000 employees, dedicated to developing our people and building an inclusive culture.

• Develop, mentor, manage and coach SSU personnel to ensure quality standards.
• Ensure SSU personnel work to the highest quality standards and maintain compliance.
• Participate in the interview process for new SSU personnel by conducting CV review.

Precision for Medicine is a Clinical Research Organization with an integrated offering enabling the science of precision medicine. They combine clinical trial designs, operational and medical experts, biomarker and data analytics solutions, with a passion for rare diseases and oncology.

• Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

• Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
• Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
• Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.

UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.

• Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
• Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
• Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.

Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.