Clinical Research Associate II, Medical Device - Boston, East Coast & Central US

Role Summary

Clinical Research Associate II, Medical Device - Boston, East Coast & Central US. We are currently seeking an experienced Medical Device CRA II residing in the Boston area, the East Coast or Central US. The CRA 2 is responsible for site monitoring and site management with responsibilities for clinical studies according to SOPs and regulatory guidelines. May assume leadership roles on projects of limited scope and may act as Local Project Coordinator or Lead CRA as assigned.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On-Site Monitoring Responsibilities: ensure staff have proper materials and instructions to safely enter patients into the study; protect study patients by ensuring informed consent procedures and protocol requirements are adhered to; ensure data integrity through source document review; monitor data for missing or implausible data; manage travel expenses in line with policy; ensure audit readiness at the site level; travel may be required and is an essential function; prepare accurate trip reports.
• Manage small projects under the direction of a Project Manager/Director; serve as lead monitor for a protocol or project and assist in monitoring plan development and trip report review; review project progress and initiate actions to achieve objectives.
• Organize and present at Investigator Meetings; participate in protocol and Case Report Form development; participate in writing clinical trial reports; interact with internal teams to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other vendors; oversee registry management; undertake feasibility work when requested; conduct, report, and follow-up on Quality Control visits.
• Recruit investigators, prepare EC submissions, regulatory notifications, translate study documentation, organize meetings; negotiate study budgets with investigators; assist with statements of agreements as assigned.
• Track SAE reporting and follow-up; perform CRF reviews and resolution; assist in training and development of new employees; coordinate designated projects as Local Project Coordinator; other duties as assigned.

Qualifications

• University or college degree (life science preferred), or related allied health certification; or 3 years of relevant clinical research experience in pharma or CRO industries.
• Thorough knowledge of regulatory requirements and the drug development process; fluent in local language and English.
• Relevant equivalent experience may be considered in lieu of educational requirements.

Experience

• Minimum 1 year of Clinical Monitoring experience.
• Understanding of SAE reporting and related documentation; advanced site monitoring and site management skills; registry administration skills.
• Ability to work with minimal supervision; strong planning, organization, and communication skills; ability to train junior staff; ability to work in a matrix environment.
• Valid Driver's License.

Preferred Qualifications

• 1+ year additional experience in related field (medical, clinical, pharmaceutical, laboratory, data analysis, data management, or technical writing).
• Local project coordination and/or project management experience.

Physical Demands/Work Environment

• Travel requirements: 60-80% overnight.
• Office environment with regular travel to client/site locations domestically and internationally.
• Physical requirements: ability to sit; repetitive hand movements; occasional crouching and twisting; lift up to 15-20 lbs; use computer software; varied hours may be required.