The Point of Care marketplace is seeking a Senior CRA in the POC space.
Full-lifecycle" CRA role for clinical trials for a product line, or multiple products, handling all aspects from site/test set-up, initiation/design/coordination of the study, execution of the trials (in hospital laboratories - not CRO's), ensuring timeline/budget/quality, document collection/mgt, and being the SME regarding any problems/resolutions during the trials. This is a fast-paced, hands-on position seeking a confident CRA who is ready to take on more responsibility.
- Initiate, design and coordination of IVD studies; collecting data to support submissions to regulatory and future product development
- Ensure the execution of clinical trials with the goal of adhering to target timelines, budget and qualityO
- Operate at a high level independently, partnering with other CRAs internally and directly reporting to the Director of Clinical/RA
- Manage clinical trials; protocol, ICF and CRF development, investigational product / supply management, budget / contract negotiation and regulatory document collecollection/management
- Monitor studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance
- Assist clinical sites with IRB submission / documentation, as needed
- Working knowledge of GCP and SOPs to assure compliance with FDA regulations and applicable processes and procedures
- Anticipate and identify problems/issues implement resolutions or provide recommendations for corrective actions in relevant job areas
- Bachelor's Degree in life science discipline desired, other degrees will be considered
- 4-12+ years experience in clinical research / trial management in a hospital, lab, or R&D environment. Pharma clinical experience will be consider if you additionally have medical/hospital laboratory experience.
- CCRA certification with ACRP or SoCRA
- Must have medical device experience OR medical/hospital laboratory experience
- Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical trial reports, etc.)
- Demonstration of effective oral communication skills with clinical sites, and internal / external personnel from various departments / levels
- Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically; <10% internationally (will coordinate/set-up the trials intiially - this is not weekly travel just periodically)
- Experience with Pre-Subs and 510k submissions desired but not required