ProPharma

Compensation

Full Description

Description: • Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies • Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships • Serve as a point of contact for investigators and site staff • Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates • Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables • Conduct thorough site qualifications visits • Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams • Conduct efficient and comprehensive site initiation visits • Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements • Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs • Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies • Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements) • Ensure all clinical site staff actively participating in the study are appropriately trained • Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team • Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team • Assist clinical site in resolving issues, if appropriate • Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.) • Communicate status of Site management activities on a routine basis to the Clinical Project team and management • Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members • Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study • Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members • Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. • Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis • Document monitoring activities in monitoring visit reports and follow-up letters • Communicate serious issues to appropriate parties, in a timely manner • Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed • Participate in Investigator Meetings, and other study trainings and meetings as required • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork • Support and comply with the company’s Quality Management System policies and procedures • Maintain regular and reliable attendance • Ability to act with an inclusion mindset and model these behaviors for the organization • Ability to work designated schedule • Ability to work nights and/or weekends, as needed • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day • Ability to work on a computer and phone simultaneously • Ability to use a telephone through a headset • Ability to travel 50% of working time away from work location may include overnight/weekend travel Requirements: • Minimum 4+ years clinical research monitoring experience or equivalent experience • Bachelor’s Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience • Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience • Proficiency in data management, including progressive experience in data entry, validation, and cleaning • Familiarity with Electronic Data Capture (EDC) systems • Effective communication skills and ability to collaborate with investigators, site staff, and team members • Demonstrated ability to work well within a team and convey information effectively • Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements • Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices • Meticulousness with a focus on accuracy and precision in all tasks and activities • Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits • Proficiency in monitoring plans, protocol adherence, and GCP guidelines • Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy • Demonstrated ability to perform the essential duties of the position with or without accommodation • Authorization to work in the United States without sponsorship. Benefits: • Diversity, equity, and inclusion initiatives • Opportunities for professional development • Flexible working environment