Senior Oversight Clinical Research Associate

March 5

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking a Sr. Oversight Clinical Research Associate to manage and oversee clinical study site activities for Apogee sponsored clinical trials. • In this role you will serve as Apogee’s primary liaison with the clinical study sites and contribute to building a culture of team, site and patient centricity. • This role is accountable for clinical site activities from site identification through close out of the study site. • The Sr. CRA has ‘in-house’ responsibilities (e.g., management/oversight of vendors, enrollment tracking), and as required by project scope, performs visits at the clinical study sites (e.g., site monitoring visits, co-monitoring visits). • The Sr. Oversight CRA collaborates closely with the Apogee 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.

🎯 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. • 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. • 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: Caring, Original, Resilient and Egoless. • Position requires up to 50% travel.

🏖️ Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. • 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.