Job Title: Sr CRA/CTM
Job Number: 32221
They are seeking an experienced, motivated Senior Clinical Research Associate or Clinical Trial Manager eager to join a fast-growing, Boston-based start-up. Our client’s diagnostic platforms will transform Infectious Diseases patient care and combat the antibiotic resistance epidemic. Our client anticipates 510k clearance for its initial rapid antibiotic susceptibility test platform in Q4-2022 and currently has a multi-site FDA clinical study underway for its second product offering.
The successful candidate will become a critical part of the team, leading relationships with each clinical site and serving as the primary point of contact with site study personnel. They will work closely with the Program Manager, Chief Technology Officer, and Director of Microbiology to ensure clinical trial milestones are achieved on time and within budget. This position offers long-term commitment – Our client plans to perform at least 4 FDA trials over the next 5 years with this position leading each, as well as the opportunity for growth and learning around Regulatory strategy. This position will be hybrid, with the expectation of being onsite at our Charlestown Headquarters at least once per week and with very limited travel to clinical sites (once-to-twice per study).
- Site qualification: Assist with and eventually oversee identification and approval of clinical sites and finalize Clinical Trial Agreement (CTA) with sites including NDAs, budgets, and study personnel financial disclosures.
- Clinical Study Protocol: Work with client R&D and Quality teams to finalize study protocols and SOPs.
- Site initiation and activation: develop site training materials and lead trainings for EDC. Work with client R&D and Service teams to develop site training materials for systems
- IRB submissions: Responsible for IRB submissions either directly or ensuring sites have IRB approval via local IRB
- Site training, monitoring and close-out: develop materials to ensure sites are adhering to trial protocols and SOPs; perform monitoring visits, including site initiations and close-outs; prepare sites for potential FDA audits
- Study supplies: coordinate shipping of supplies throughout the study to ensure all components and general lab supplies are available at each site for successful and timely sample processing
- Create and maintain Trial Master File and Study Binders
- Site communication: serve as key liaison between client and clinical study sites; responsible for resolving issues at clinical sites, including service calls and data entry questions
- Site progress monitoring: track the progress of samples collected (enrolled) at each site to ensure the proper number of samples are tested and throughputs are acceptable
- Data management: database development, validation, maintenance, and support; develop EDC training materials
- Clinical study report writing: draft clinical study report at conclusion of study for submission
- A Bachelors degree or higher in a scientific or biological discipline (microbiology experience preferred)
- 5 years clinical research experience in the medical device/IVD industry
- Experience leading site-sponsor relationships
- ACRP or CCRP certificate is a plus
- Experience with 510k trials
- Experience writing clinical study reports and developing clinical trial databases
- Experience performing site activations, monitoring visits, and close-outs
- Experience writing training materials for site activations
- Experience leading clinical study logistics
- Analytical and creative thinking skills
- Excellent attention to detail and the ability to keep detailed accurate records
- Strong written and verbal communication skills
- Ability to work collaboratively and problem solve
- Proficiency in MS Word, Excel and Power Point
- Organizational and planning skills
- Ability to travel to US-based sites for 1-2 days at a time during 6-month study periods (~10% travel)
- Passion about an early-stage start-up that aims to change industry and how healthcare is delivered!