[Hiring] Site Monitor @Discovery Life Sciences

Role Description

The Site Monitor, Clinical Affairs contributes to our mission by monitoring our clinical site network which supports data quality and integrity and ensures adherence to procedures and protocols. This individual will collaborate with other members of the Clinical Affairs team to monitor while working cross-functionally with internal and external stakeholders to execute processes for maximum effective and efficient performance.

A Day in the Life of a Manager, Clinical Affairs at Discovery Life Sciences:

• Conduct and Document Site Monitoring: Perform regular remote or on-site monitoring visits to ensure compliance with clinical protocols, resolve outstanding issues, and compile detailed monitoring reports.
• Partner with Clinical Teams: Collaborate with Clinical Affairs Managers and site personnel to ensure accurate regulatory documentation, data integrity, and protocol adherence across clinical trial sites.
• Proactively Address Site Issues: Identify and resolve site-specific challenges—supporting retraining, corrective actions, and continuous process improvements to maintain quality standards.
• Stay Organized and Travel-Ready: Manage timelines and documentation across multiple sites while traveling up to 50% of the time to support ongoing clinical trials and site performance.

Qualifications

• 5+ years of experience in clinical trial research with monitoring oversight preferred
• 3-5 years of comparable or related medical experience
• Experience in a clinical research organization or oncology/infectious disease/autoimmune therapeutic specialties with familiarity of principles, concepts, standards of care and clinical study design
• Highly developed organizational and analytical skills with the ability to multitask, prioritize time-sensitive activities and work both independently and as part of a team in a matrix environment
• Excellent presentation, communication and relationship-building skills
• Thrive in a challenging and results-oriented work environment
• Demonstrate ability to develop trust and maintain integrity with external clinical and scientific experts, institutions, peers, and others
• Proven ability to analyze problems, develop and implement strategic solutions to optimize and maximize systems
• Ability to work independently as well with interdisciplinary teams (internal and external)
• Strong proficiency with MS Suite
• SalesForce.com and MediaLab experience is desirable but not required
• Ability to travel to clinical sites up to 50% of the time
• Preferred home base near an international airport
• Experience with electronic medical records (EMR) is desirable but not required

Requirements

• Manage, coordinate, and support clinical site monitoring activities
• Conduct visits and partner with the Clinical Affairs Manager to schedule the visit, obtain proper access, and complete the overall Monitoring plan. This includes preparing reports and all applicable correspondence
• Perform general monitoring functions of review data according to monitoring guidelines, ensure all documentation is present, and compile findings
• Monitor on client projects as required by researchers, biopharmaceutical, etc., including enrollment updates
• Resolve issues from previous visits, address protocol questions, and ensure outstanding documents are completed properly
• Collect regulatory documentation, file properly, and ensure accuracy
• Update site specific files
• Partner with Quality and the site’s Clinical Affairs Manager on promptly reportable incidents (PRIs)
• Resolve site and/or monitoring issues including appropriate retraining, issue escalation, and implementation of corrective actions to prevent recurrence, as needed
• Review monitoring reports and protocol deviations to identify site- and study-level trends
• Proactively develop study materials that aid the Clinical Affairs team and site. Mitigate risk by assisting in the improvement of current study documents.
• Travel to clinical sites at a minimum of an annual basis when remote monitoring option is not available
• Maintain and grow collaborative relationships with all Discovery personnel
• Participate and take initiative in process improvement activities for department
• Stay abreast of industry-accepted procedures and educate fellow team members of standards/policy
• Collaborate with team members to develop improved methods of tracking study information
• Maintain accurate data in SalesForce database and utilize communication tools
• Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the company interacts

Benefits

• Competitive salary and benefits package options including medical, dental, vision, life, and disability which start on your first day of employment!
• 401(k) match program which starts on your first day of employment
• Time away from work (Generous vacation and paid time off, paid parental leave, paid family leave, etc.)
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity.
• Team-building activities and social events.
• Employee Referral Program and Colleague Recognition Program