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Lead Clinical Research Associate

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Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The in-house Lead Clinical Research Associate (LCRA) will provide support for study management tasks in collaboration with the Clinical Trial Manager and Director with an emphasis on leading monitoring oversight activities for our clinical CROs. The LCRA works with clinical to assure that protocol requirements, laboratory collections, regulatory guidelines and timelines are met.

Position Responsibilities:

Serves as a representative of Scholar Rock to CRO, study vendors, and site staff
Create CRA training materials and ensure the CRO CRAs are adequately trained and are prepared to train the study site staff
Review Monitoring Visit Reports from the CRO
Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed
Develop and monitor metrics to evaluate the CRO CRAs and site performance and ensure compliance with ICH-GCP, SOPs, Local Laws & Regulations, Protocol, Monitoring Plan and associated documents
Ensure the Trial Master File is maintained in an inspection-ready state at the CRO. Review for compliance and address findings as needed
Oversee the setup activities and activation at the study sites
Assist the Clinical Trial Manager in the review of ICFs and essential documents
Participate in investigator meetings and assist with planning
Collaborate with the CRO counterpart
Travel, including international travel, required

Candidate Requirements:

BS/BA degree in a scientific discipline; advanced degree preferred
Minimum of 3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical and/ or CRO company
Highly organized, outcome oriented, self-motivated performance
Ability to adapt to change in a growth environment
Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
Knowledgeable of Electronic Data Capture and other IT systems (CTMS, Microsoft Office, etc.)
Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
Strong written and oral communication skills
Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Average salary estimate

$100000 / YEARLY (est.)

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$80000K

$120000K

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What You Should Know About Lead Clinical Research Associate, Scholar Rock

Are you ready to take the lead in clinical research? Scholar Rock is on the hunt for a Lead Clinical Research Associate (LCRA) who will play a pivotal role in our remote team, collaborating closely with our Clinical Trial Manager and Director to oversee monitoring activities for our clinical CROs. At Scholar Rock, we're dedicated to developing life-changing therapies for serious diseases, and as an LCRA, you'll be at the forefront of that mission. Your primary focus will be to ensure protocol adherence and regulatory compliance while also supporting our international sites. You'll be responsible for creating training materials for CRO CRAs, conducting monitoring visits, and maintaining the Trial Master File in an inspection-ready state. With your keen analytic skills, you’ll assess performance metrics to guarantee our partners meet ICH-GCP and local regulations. Join us in exploring novel treatment avenues where growth factors are central, and contribute to revolutionary developments in conditions like spinal muscular atrophy. We thrive on innovation, collaboration, and a fierce commitment to improving patient outcomes. If you’re a highly organized, self-motivated professional with at least 3 years of clinical oversight experience, we want to hear from you! Discover the difference Scholar Rock makes every day through our cutting-edge science and diverse work environment where every voice matters.

Frequently Asked Questions (FAQs) for Lead Clinical Research Associate Role at Scholar Rock

What are the primary responsibilities of a Lead Clinical Research Associate at Scholar Rock?

The Lead Clinical Research Associate (LCRA) at Scholar Rock is responsible for overseeing clinical trial activities, ensuring compliance with regulatory guidelines, and working closely with CROs. Key tasks include developing training materials for CRO CRAs, conducting monitoring visits, and maintaining the Trial Master File. The LCRA also evaluates site performance and collaborates with stakeholders to optimize clinical study management.