Lead Clinical Research Associate - Respiratory
October 11
Description
• We are seeking a Lead Clinical Research Associate (LCRA) to manage and oversee in-house 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 partner and sites will be critical.
Requirements
• Bachelor's degree in a scientific or healthcare-related field • Minimum of 8-10 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 • Certification as a Clinical Research Associate (CCRA) or equivalent preferred • Knowledge of therapeutic areas relevant to Apogee’s portfolio a plus • Ability to travel up to approximately 35% including travel to company meetings at least twice per year
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
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