On-site Monitor

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

📋 Description

• Execute site management tasks in alignment with the Company's and Sponsor's (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs).

• Ensure adherence to local regulations and relevant guidelines based on the assigned study design/classification.

• Carry out site management responsibilities according to the agreed Scope of Work (SoW), Site Management Plan (SMP), and applicable guidelines.

• Identify potential sites by reaching out to gauge their interest in study participation, confirming contact information, and gathering necessary documents.

• Site Qualification - Guarantees the selection of suitable sites for the studies assigned.

• Site Start-Up – Capable of performing start-up activities for assigned sites with minimal supervision, collaborating with study start-up and regulatory teams.

• Conduct all remote and on-site monitoring tasks throughout all phases of the study.

• Regularly examine the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

• Reconcile the contents of the ISF with the Trial Master File (TMF).

• Ensure that the investigator/physician site is informed of the need to archive essential documents per local guidelines and regulations.

• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documents in accordance with SOPs and SMP, adhering to required timelines.

• Assist with subject/patient recruitment, retention, and awareness initiatives.

• Input data into tracking systems as needed to monitor all observations, ongoing status, and assigned action items until resolved.

• Display diligence in safeguarding the confidentiality of each subject/patient.

• Review assigned site data, aiding with data query resolution and follow-up on missing data (as applicable).

• Analyze data using trend reports and knowledge of site practices.

• Ensure the resolution of data queries within agreed timelines.

• Utilize available hardware and software to facilitate effective study data collection and review.

• Maintain effective, accurate, and timely communication with site personnel and project teams, ensuring appropriate issue escalation and resolution as per SOPs with a focus on preventing issues.

• Manage clinical tracking and management systems effectively.

• Ensure all assigned sites are trained and compliant with study protocol requirements, informed consent processes, data collection needs/data collection tools, and safety reporting.

• Provide guidance at both the site and project levels regarding audit readiness standards, supporting audit preparation and subsequent required actions.

• Prepare for, attend, and engage in Investigator Meetings and/or sponsor face-to-face meetings.

• Collaborate with and establish relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff as required.

• Understand project scope, budgets, and timelines for assigned activities; manage site-level communication to ensure project objectives, deliverables, and timelines are met.

• Quickly adapt, under the supervision of the Clinical Operations Lead or designee, to changing priorities to meet goals/targets.

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

• Participate in, contribute to, and present at study and department meetings.

⛳️ Requirements

• At least 1 year of relevant onsite monitoring experience is required.

• BA/BS degree in a science/healthcare field or nursing degree, or equivalent combined education and experience.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email/voicemail, and Clinical Trial Management and EDC systems is essential.

• Prior experience in site management (in-house, on-site, Study Coordinator) or equivalent roles.

• Strong communication, time management, organizational, documentation, and customer service skills.

• Knowledge of local requirements for Real World Late Phase study designs, as well as Real World Research and relevant regulations including GPP.

• Exceptional customer focus (internally and externally) with the ability to interact professionally with client organizations and study sites.

• Willingness to work in a team-oriented environment.

• Capability to work in a “virtual” team setting and independently, seeking guidance as needed.

• Ability to manage multiple tasks (across different studies as necessary) and prioritize effectively to meet study timelines.

• Strong problem-solving and analytical skills.

• Proficient in both written and spoken local language, in addition to English.

• Ability to foster good working relationships through effective oral communication and telephone etiquette.

• Willingness to travel up to 60% regularly, depending on assignments and study phases.

🏝️ Benefits

• We are committed to developing our people through career growth and advancement.

• Supportive and engaged line management.

• Comprehensive technical and therapeutic area training.

• Peer recognition and a total rewards program.

• Dedicated to fostering an inclusive culture – where you can truly be yourself.