Lead Clinical Research Associate

Apogee Therapeutics; United States; Remote; USD 135,000 - 170,000; Full time

Job summary

An innovative biotechnology company is seeking a Lead Clinical Research Associate to drive clinical trials and oversee a dedicated team. In this pivotal role, you'll ensure that clinical studies align with regulatory standards and company objectives, while fostering a collaborative culture focused on patient-centricity. This is a unique opportunity to shape the future of treatments for inflammatory diseases in a dynamic environment. If you're passionate about making a difference and thrive in fast-paced settings, this role is perfect for you.

Benefits

Flexible PTO

Performance bonus

Equity grant opportunities

Health benefits

Retirement benefits

Company-wide shutdowns

Professional development resources

Qualifications

• 8+ years of CRA experience in pharmaceuticals or biotechnology.
• 2+ years leading a team of CRAs with strong regulatory knowledge.

Responsibilities

• Oversee in-house CRAs and manage clinical study site activities.
• Ensure compliance with GCP, SOPs, and study-specific requirements.

Skills

Clinical Research

Team Leadership

Regulatory Compliance

Communication Skills

Organizational Skills

Education

Bachelor's degree in a scientific or healthcare-related field

Tools

Microsoft Office Suite

EDC systems

electronic trial master files (eTMFs)

Smartsheet

Job description

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 manage 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, liaising with clinical study sites and contributing 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 closeout 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 ensure 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.
• Review and approve time sheets and expense reports.
• Assist with review and revision of departmental SOPs and policies.
• Assist with creation and delivery of new department initiatives, improvement plans, or training.
• May assist with the identification and selection of appropriate clinical trial sites and investigators.

Field monitoring responsibilities

• 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.

Ideal Candidate

• 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 of 2 years of experience leading a team of CRAs.
• Recent experience working on respiratory, dermatology, and/or gastrointestinal clinical trials a plus.
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred.
• Recent experience working on trials utilizing risk-based monitoring models.
• 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: Caring, Original, Resilient, and Egoless.
• Position requires approximately 35% travel, including travel to company meetings at least twice per year.

The anticipated salary range for candidates for this role will be $135,000 - $170,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, educational background, and geography.

What We Offer

• 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.

E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.