Site Navigator I – II

This is a fully remote position, open to applicants in United States, +1 more state.

📋 Description

• Oversee site-level operations throughout the initiation and potential conclusion of clinical studies.

• Act as the primary liaison for investigative sites from feasibility assessments and outreach to activation and ongoing support.

• Ensure adherence to regulatory standards, effective site management, site assistance and training, and collaboration among sponsors, CROs, and clinical site personnel.

• Identify and evaluate potential research sites.

• Conduct outreach to sites, gather confidentiality agreements, and collect feasibility surveys.

• Manage site-level activities, address issues, and support study timelines and compliance.

• Perform remote pre-study visits and complete necessary follow-up documentation.

• Assist in the customization and translation of informed consent forms and patient-facing materials.

• Gather, track, and quality-review essential documents required for site activation.

• Maintain site regulatory compliance, including IRB/IEC renewals, changes in Principal Investigators, and document expiration management.

• Participate in study team meetings and create action plans for site-related risks and issues.

• Support CRA teams in preparing for site initiation visits, including coordination of supplies, access, and necessary documents.

• Submit requests to and communicate with IRBs/IECs, Third Bodies, and Regulatory Authorities.

• Conduct initial and modified contract and budget negotiations with sites.

• Keep accurate filing systems and maintain an audit-ready Trial Master File.

• Monitor the start-up progress and ensure that sites adhere to requirements and deadlines.

• Serve as the main point of contact for investigative sites, ensuring timely delivery within the defined scope and budget.

• Execute CRF reviews and validate data against source documentation.

• Monitor protocol deviations and the reporting of Serious Adverse Events.

• Review and customize country-specific and site-specific informed consent forms.

• Perform other assigned responsibilities.

⛳️ Requirements

• Preferred university/college degree in life sciences, or certification in a related allied health profession from an accredited institution, or 2–3 years of clinical research experience.

• Relevant experience may be accepted as a substitute for educational qualifications.

• A High School Diploma or equivalent along with at least 5 years of clinical research experience is also an acceptable qualification.

• Proficient understanding of ICH/GCP guidelines and regulations of regulatory authorities and IRBs/IECs.

• Fluency in the local official language and English, both written and verbal.

• A minimum of 1 year of experience in a related area, such as medical, clinical, pharmaceutical, laboratory research, data analysis, data management, or technical writing.

• One year of clinical research experience is preferred.

• Basic knowledge of ICH/GCP, regulatory authorities, IRB/IEC, and relevant regulations/guidelines.

• Familiarity with investigator start-up documents and the processes for contract/budget negotiations.

• Understanding of research protocol requirements.

• Capability to communicate effectively with site staff, CRO personnel, and regulatory authorities.

• Ability to manage multiple tasks and meet deadlines.

• Skill in identifying and resolving start-up challenges.

• Proficiency in negotiating contracts and budgets with research sites.

• Competence in utilizing in-house and commercial computer software.

• Ability to sit for extended periods and operate a vehicle safely.

• Capacity to perform repetitive hand movements.

• Ability to lift and carry 15–20 lbs.

• Commitment to regular and consistent attendance.

🏝️ Benefits

• Opportunity for remote work.

• Limited travel required for training purposes only.

• EEO and accommodations support provided.

• Commitment to regular and consistent attendance.

• Flexibility in working hours may be necessary.