Senior CRA / Lead CRA
Capricor, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment of rare disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor has also established itself as one of the leading companies investigating the field of extracellular vesicles, exosomes, and is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com. Capricor recently open up a new Clinical Operations office in San Diego and has an opening for a Senior CRA/Lead CRA.
The Senior CRA/Lead CRA will be responsible for the oversight of study monitoring (feasibility, site selection, study start-up, enrollment, conduct and close-out) by independent CRAs as well as retain primary monitoring responsibilities for at least 2-3 sites. The Senior CRA/Lead CRA will ensure monitoring consistency for all clinical development programs, including consistent study execution through the development of supporting study documents, such as monitoring plans, case report forms and site audit plans, as well as input into other study documents (eg, data management plans). CRAs serve as the primary point of connect between Capricor and investigative site personnel. Other responsibilities include, but are not limited to, the following:
- Mentoring and supervising contract CRAs performing on-site monitoring services for Capricor.
- Providing strategic direction to the clinical team and ensuring staff development, training and performance feedback are properly implemented. Building talent and capabilities of team members through proactive coaching, mentoring and development opportunities.
- Directing daily activities for the contract CRAs and other team members and monitoring program metrics, including measures of data quality, ensuring consistency and predictable study progress.
- Ensuring appropriate resources are available to meet corporate and project objectives while achieving optimal utilization of the staff.
- Overseeing program communications including internal and external communications.
- Forecasting appropriate timelines for Capricor’s clinical studies and communicating timelines with the project team and contract CRAs.
- Actively identifying issues and challenges that present barriers to program success and developing and implementing appropriate solutions.
- Developing company policy on risk-based monitoring and its implementation plan into clinical programs.
- If requested, contributing to the preparation of various clinical research documents, such as clinical protocols, clinical study reports, regulatory agency update reports, and responses to regulatory agencies.
Required Educational Background and Skills:
- Bachelor’s Degree and/or equivalent with at least 5-6 years of monitoring experience in the biopharmaceutical industry.
- Working knowledge of FDA regulations, DIA Reference Model and ICH guidelines regarding GCPs.
Knowledge, Skills and Attributes:
- Proven ability to multi-task and prioritize.
- Well-organized, detail-oriented, possess a sense of urgency.
- Team-oriented with very good communication and interpersonal skills.
- Excellent computer skills in the following programs: Microsoft Outlook, Word, PowerPoint and Excel.