Site Monitor

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

📋 Description

• Oversee the clinical site network to uphold data quality and integrity while ensuring compliance with established procedures and protocols.

• Conduct and document regular monitoring visits, either remotely or on-site.

• Address outstanding issues and prepare comprehensive monitoring reports.

• Collaborate with Clinical Affairs Managers and site staff regarding regulatory documentation, data integrity, and adherence to protocols.

• Identify and tackle site-specific challenges, including retraining, corrective actions, and escalation of issues.

• Manage timelines and documentation across various clinical trial sites.

• Organize, coordinate, and assist in clinical site monitoring activities.

• Schedule visits, secure necessary access, and finalize monitoring plans in conjunction with the Clinical Affairs Manager.

• Review data according to monitoring standards, ensure documentation is complete, and compile findings.

• Monitor client projects as needed by researchers and biopharmaceutical clients.

• Address protocol inquiries and confirm that outstanding documents are correctly completed.

• Collect, accurately file, and update both regulatory and site-specific documentation.

• Collaborate with Quality and the site’s Clinical Affairs Manager on incidents that require prompt reporting.

• Review monitoring reports and protocol deviations to identify trends at both the site and study levels.

• Develop study materials and enhance study documentation to mitigate risks.

• Travel to clinical sites at least once a year when remote monitoring is not an option.

• Foster collaborative relationships with Discovery personnel.

• Engage in departmental process-improvement initiatives.

• Stay updated on industry-recognized procedures and educate team members on standards and policies.

• Work together to enhance study-information tracking methods.

• Maintain accurate data in the Salesforce database and utilize communication tools effectively.

• Safeguard the privacy of patients, co-workers, and other individuals’ personal information.

⛳️ Requirements

• A minimum of 5 years of experience in clinical trial research, with a preference for those with monitoring oversight.

• 3 to 5 years of relevant medical experience.

• Experience within a clinical research organization or in oncology/infectious disease/autoimmune therapeutic areas.

• Understanding of principles, concepts, standards of care, and clinical study design.

• Strong organizational and analytical skills.

• Capability to multitask, prioritize time-sensitive tasks, and work both independently and in a matrix environment.

• Exceptional presentation, communication, and relationship-building abilities.

• Ability to build trust and maintain integrity with external clinical and scientific experts, institutions, peers, and others.

• Skill in analyzing problems and formulating and implementing strategic solutions.

• Ability to work both independently and collaboratively within interdisciplinary teams.

• High proficiency in MS Suite.

• Willingness to travel to clinical sites up to 50% of the time.

• Preferred home base should be in proximity to an international airport.

• Familiarity with Salesforce.com and MediaLab is desirable but not mandatory.

• Experience with electronic medical records (EMR) is a plus but not required.

• Must be available to work Monday through Friday, with a start time between 7am and 9am local time.

• Applicants must possess authorization to work in the United States; visa sponsorship is not available.

🏝️ Benefits

• Medical, dental, vision, life, and disability benefits commencing on the first day of employment.

• 401(k) match program starting on the first day of employment.

• Generous vacation and paid time off policies.

• Paid parental leave.

• Paid family leave.

• Opportunities for professional development.

• Reimbursement for relevant certifications.

• A collaborative and inclusive work environment that values diversity.

• Team-building activities and social events.

• Employee Referral Program.

• Colleague Recognition Program.