Lead Clinical Research Associate

Summary

Join Apogee Therapeutics as a Lead Clinical Research Associate (LCRA) and oversee in-house and CRO CRAs managing clinical study site activities. You will be the primary liaison with CRAs and clinical sites, contributing to a patient-centric culture. Responsibilities include overseeing clinical monitoring activities, supporting study team activities, and ensuring compliance with regulations. The role requires a Bachelor's degree, 8+ years of CRA experience, and 2+ years leading a CRA team. Preferred qualifications include experience with respiratory, dermatology, or gastrointestinal trials and risk-based monitoring. Apogee offers a competitive compensation and benefits package, including flexible PTO, company-wide shutdowns, and professional development opportunities.

Requirements

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 8 years of experience as a CRA or related role within the pharmaceutical, biotechnology, or medical device industry
• Minimum 2 years of experience leading a team of CRAs
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet
• Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
• Strong understanding of clinical trial processes and study conduct
• 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

Responsibilities

• Ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• Be responsible for the hiring of in-house CRAs
• Input into and assist with the development of study documents (e.g., protocols, case report forms, informed consent forms)
• Oversee development and implementation of project specific processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Support the training and development of in-house CRAs and ensuring study training compliance is maintained
• Work with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
• Oversee the review of monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Be responsible for oversight of CRA review of clinical data (e.g. electronic case report forms, eCOA data, central laboratory data, risk-based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site’s data with quality and integrity
• Be responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Be responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Lead, conduct, and document regular meetings with their in-house and CRO CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Oversee the study specific performance of the CRA team(s) and implement plans of action as needed; escalate performance issues to the Executive Director, Clinical Operations
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with review and revision of departmental SOPs and policies
• Assist with creation and deliver new department initiatives, improvement plans or training
• May assist with the identification and selection of appropriate clinical trial sites and investigators
• Conduct CRO co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
• Oversee CRO site visits to qualify, initiate, and close-out study sites, and perform site monitoring to ensure study sites’ compliance with study timelines, protocol requirements, and applicable regulatory guidelines
• Review and ensure data integrity, accuracy, and completeness at the clinical study sites
• Escalate site related issues to the study team
• Oversee the coordination for study site audit and ensure assigned study sites are inspection-ready, as needed

Preferred Qualifications

• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials
• Certification as a Clinical Research Associate (CCRA) or equivalent
• Recent experience working on trials utilizing risk-based monitoring models

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