Lead Clinical Research Associate

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a Lead Clinical Research Associate (LCRA) to oversee in-house Oversight CRAs that will oversee CRO CRA’s management of clinical study site activities for Apogee sponsored clinical trials. This role will also support the study team in various trial related activities. In this role, you will serve as Apogee’s primary liaison with the in-house CRAs and CRO clinical monitoring team and liaise with clinical study sites and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role is accountable for oversight of clinical monitoring activities from site identification through close out of the study site. The LCRA has ‘in-house’ responsibilities (e.g., oversight CRAs), and as required by project scope, performs sponsor monitoring or co-monitoring visits at the clinical study sites.

The LCRA collaborates closely with the Apogee Executive Director, Clinical Operations and the Clinical Study Lead, assists in the planning/management/execution of Apogee sponsored clinical trials, and contributes to the overall success of the clinical study according to company and department objectives.

Key Responsibilities

In-house responsibilities

• The Lead CRA is responsible for the study deliverables of in-house CRAs on a given study(s), ensuring 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
• May 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
• Works with the study team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery
• Oversight of 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
• 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
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• 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