Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
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.
- 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
- 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.