Offer summary

Qualifications:

BS/BA degree in a scientific discipline; advanced degree preferred, Minimum of 3 years site monitoring experience in biotechnology, pharmaceutical, or CRO, Strong understanding of clinical research and GCP/ICH guidelines, Excellent interpersonal and communication skills, with conflict management abilities..

Key responsabilities:

Serve as a representative of Scholar Rock to CROs and study vendors

Create and oversee CRA training materials and ensure adequate training for site staff

Monitor studies and develop metrics to evaluate CRO and site performance

Ensure compliance with regulatory guidelines and maintain the Trial Master File in an inspection-ready state.

Job description

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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