Site Management Associate

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Execute site management responsibilities in accordance with Company and Sponsor Standard Operating Procedures (SOPs) and Work Instructions.

• Ensure adherence to local regulations and relevant Good Pharmacoepidemiology Practices (GPP) and/or ICH-GCP guidelines.

• Carry out site management tasks as outlined in the Scope of Work, Site Management Plan, and pertinent guidelines.

• Identify potential sites and reach out to them regarding involvement in studies, including contact details and necessary documentation.

• Evaluate and select suitable sites for designated studies.

• Conduct site initiation activities in collaboration with study start-up and regulatory teams.

• Perform both remote and on-site monitoring throughout all phases of the study.

• Assess Investigator Site Files for accuracy, timeliness, and completeness, and ensure reconciliation with Trial Master Files.

• Record site activities and enter data into tracking systems.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Safeguard the confidentiality of subjects/patients.

• Analyze assigned-site data, assist in resolving data queries, and follow up on any missing information.

• Maintain prompt communication with site personnel and project teams, escalating issues when necessary.

• Oversee clinical tracking and management systems.

• Ensure that assigned sites receive training and remain compliant with study requirements.

• Offer guidance on site and project matters to ensure audit readiness, and support audit preparations and follow-ups.

• Participate in Investigator Meetings and sponsor meetings.

• Collaborate with Sponsor affiliates, medical science liaisons, and local sponsor representatives.

• Manage site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Identify and report any out-of-scope activities to the Clinical Operations Lead.

• Attend, contribute to, and present at study and department meetings.

⛳️ Requirements

• Demonstrated experience and expertise in site management and clinical operations.

• Capability to execute site management activities in compliance with Company and Sponsor SOPs and Work Instructions.

• Familiarity with local regulations, Good Pharmacoepidemiology Practices (GPP), and/or ICH-GCP.

• Proficiency in conducting site identification, qualification, and initiation tasks.

• Competence in performing remote and on-site monitoring throughout all stages of the study.

• Ability to review and reconcile Investigator Site Files (ISF) with Trial Master Files (TMF).

• Skill in documenting activities through confirmation letters, follow-up correspondence, trip reports, communication logs, and project documents.

• Ability to support initiatives for subject/patient recruitment, retention, and awareness.

• Proficiency in reviewing study data, resolving data queries, and following up on any missing data.

• Familiarity with hardware, software, clinical tracking, and management systems.

• Effective communication skills with site personnel and project teams, with an ability to escalate issues when appropriate.

• Capacity to ensure that sites are properly trained and compliant with study protocols, informed consent, data collection, and safety reporting requirements.

• Ability to assist with audit readiness and follow-up actions after audits.

• Understanding of project scope, budgets, timelines, and site-level deliverables.

• Ability to adapt to shifting priorities.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.

• Reasonable accommodations available when appropriate.