Senior Clinical Trial Specialist
Cambridge, MA /
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By exploiting structural differences in the precursor, or latent form of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation 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.
Our second product candidate, SRK-181, is a potent and highly selective inhibitor of latent TGFβ1 activation. A Phase 1 proof-of-concept trial will be initiated in Q1 2020 in patients with solid tumors. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from checkpoint inhibitor therapy by overcoming primary resistance to anti-PD-(L)1 antibodies.
Summary of Position:
This role represents a great opportunity to be a part of a growing clinical organization. Reporting to our Sr. Director of Clinical Development, the Senior Clinical Trial Specialist will support a variety of tasks and projects related to study management from start-up through closeout.
- Responsible for taking and distributing meeting minutes for both internal and external meetings, on site and via teleconferences.
- Scheduling activities and setup videoconferencing sessions, including compilation of materials and overseeing presentations
- Review study vendor meeting minutes and documents for accuracy.
- Management of agreements related to Clinical Operations.
- Preparing and tracking green light packets / essential document packets for review.
- Updating trackers for metric reporting
- TMF and file maintenance
- Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.
- Assists with preparation of reports and technical or scientific publications, as required.
- Bachelor’s Degree Preferred
- 5+ years of experience in a clinical research administration function, including hands on experience relating to the essential documentation of a clinical trial. Experience supporting Drug or Biologics trials strongly preferred.
- Good computer skills including knowledge of Databases, Outlook, Excel, Word, PowerPoint, and videoconference software.
- Good understanding of the policies and procedures of Clinical Operations and ICH-GCP, particularly relating to essential documentation
- Good time and priority management, able to work efficiently under pressure
- Good organizational and problem solving skills
- Self-motivated, shows initiative, is proactive and able to work on his/her own as well as in a team
- Good communication skills - both verbal and written
- Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.