Senior Oversight Clinical Research Associate

Summary

Join Apogee Therapeutics as a Sr. Oversight Clinical Research Associate to manage and oversee clinical study site activities for Apogee-sponsored clinical trials. You will serve as the primary liaison with clinical study sites, contributing to a patient-centric culture. Responsibilities encompass site activities from identification to closeout, including in-house tasks like vendor management and enrollment tracking, and on-site visits for monitoring and compliance. Collaboration with the Clinical Study Lead and participation in internal and external meetings are key aspects of this role. The position requires a strong understanding of GCP, ICH guidelines, and FDA regulations, along with experience in clinical trial management and site monitoring. Apogee offers a competitive compensation and benefits package, including flexible PTO and professional development opportunities.

Requirements

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 5 years of both monitoring experience and experience as a Sr. CRA/CRA from the biotechnology industry
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Excellent organizational and time management skills
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment, but can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Successfully exhibit Apogee’s C. O.R.E. values: C aring, O riginal, R esilient and E goless
• Position requires up to 50% travel

Responsibilities

• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Draft or assist with the development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates)
• Coordinate or manage, either directly or through supervised delegation, study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality
• Assist with the identification and selection of appropriate clinical trial sites and investigators
• Participate in internal study team meetings (e.g., protocol deviation review) and external team meetings (e.g., sponsor-vendor meetings) and draft meetings minutes as required
• Assist with investigator meeting preparations, including the creation of training materials for both CROs and clinical study sites, and help coordinate the investigator meeting planning and logistics
• Track study metrics (e.g., enrollment) for report to management
• Assist with the review and approval of site visit reports; ensure resolution of action items in a timely manner
• Collate and track site protocol deviation and non-compliance for study team review
• Oversee and/or provide study specific training [e.g., SIV, eData Capture (eDC), study specific procedures and assessments, drug accountability] to study site staff
• Oversee and/or perform site visits to qualify, initiate, and close-out study sites, and perform co-monitoring visits to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines and monitor CRO CRA’s performance
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Assist with the coordination for study site audit and ensure assigned study sites are inspection-ready
• Oversee drug supply inventory and compliance

Preferred Qualifications

• Dermatology, Respiratory and or Gastrointestinal experience a plus
• Experience performing PSSVs, SIVs, interim monitoring and closeout visits.  Experience monitoring from the beginning of the trial to the end of the trial
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Experience performing site activations, IRB submission, drug supply management, essential document review & “green light” process, etc
• Support of in-house team strongly preferred

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve