CCRA (Certified Clinical Research Associate), CCRP (Certified Clinical Research Professional)
4 Year Degree
The Regional CRA II is responsible for scheduling and conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures and IRB/EC policies and procedures). The RCRA II conducts monitoring visits as identified by the monitoring plan, study team or department needs to evaluate data accuracy and subject safety by review of regulatory documents, medical records, reported data and device storage, if applicable. The RCRA II must be able to identify issues, present findings to the site staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. The RCRA II works on a minimum of 2 therapeutic areas (Electrophysiology, Vascular Intervention and/or Neuromodulation).
Location to be based out of the NorthEast/MidAtlantic area of the United States.
Conducts monitoring within timelines and according to the monitoring plan guided by our risk-based monitoring (RBM) model and BIOTRONIK procedures. The RBM model includes a combination of on-site monitoring visits, remote monitoring visits and centralized monitoring.
Works cooperatively with Research Coordinators and Investigators to schedule and conduct monitoring visits.
Evaluate quality and integrity of site practices while escalating quality issues as appropriate.
Works cooperatively with the BIOTRONIK Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and pro-actively provides input on site performance.
Adequately prepares for monitoring visits to ensure monitoring activities are organized, well planned, efficient and thorough. Prepares site email 1-2 weeks prior to on-site and remote monitoring visits. Maximizes time on-site through visit preparation.
Conducts on-site monitoring visits per the department SOPs and monitoring plans. Applies FDA regulations, ICH/GCP guidelines and BIOTRONIK SOPs to monitoring activities.
Presents findings to site staff. Provides clear directions for resolution. Provides appropriate retraining. Reviews data queries with site staff to ensure are understood and can be resolved.
Serves as a resource to clinical site staff between visits to provide clarification and insights regarding data queries, action items and visit preparation.
Completes professional, accurate and succinct queries, Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per BIOTRONIK procedures.
Professionally documents monitoring visit action items. Action items will clearly identify the issue and suggest accurate instructions for resolution.
Assists the Manager, RCRA Group with team, department and study related projects as requested including in-house audits, investigator meetings, training, etc.
Performs centralized monitoring per monitoring plans and department needs within the established timelines and follows queries to resolution.
Interfaces with Clinical, Regulatory, Sales and administrative staff as necessary to accomplish the above responsibilities.
Complies with the BIOTRONIK Travel Policy. Completes and submits accurate expense reports. Travel air reservations booked at least 2 weeks prior to travel per travel policy.
Approximately 70% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office. The travel percentage may vary based on the study-specific risk based monitoring plans. Travel may be conducted via air travel, driving or train.
Bachelor’s or higher level degree in a life sciences, nursing or other health related disciplines.
Must have a valid US driver’s license.
Working knowledge of Electrophysiology, Vascular Interventional Cardiology and Neuromodulation
A minimum of 3 years on-site monitoring research experience.
Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP).
Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials. Strong compliance focus.
Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge.
Ability to train on site staff on the protocol, GCPs, data entry and other pertinent regulations
Conduct training visits and co-monitoring visits.
Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams.
High attention to detail and accuracy
Experience working independently in a regional area with remote or minimal supervision
Proficient knowledge of medical terminology
Effective time management and organizational skills.
Excellent professional writing and oral communication skills.
Excellent interpersonal skills.
Experience with spreadsheets, and databases applications (e.g., MS Word and Excel)
Ability to work independently within BIOTRONIK systems.
Ability to work independently and as a part of a team.
Ability to lift 25 or more pounds.
Responsible for adequate and reasonable home office set up including dedicated desk space to accommodate work responsibilities and BIOTRONIK supplied equipment.
Internal Number: 26374
About Biotronik, Inc.
BIOTRONIK is a leader in cardio- and endovascular medical technology (pacemakers, implantable defibrillators, stents and remote patient management).
We put our heart in it.
From its headquarters in Berlin, Germany, BIOTRONIK operates in more than 100 countries around the world, offering products and services essential to the lives of people living with cardiac conditions. BIOTRONIK employs highly committed employees who undertake tenacious research and development and meticulous manufacturing to meet this huge responsibility. BIOTRONIK´s products are designed, produced and sold by people who put their hearts into their work.
Quality in every detail.
From the very start, BIOTRONIK dedicated itself to driving progress and innovation and delivering exceptional quality. We have earned the trust of medical professionals and patients by combining the renowned art of German engineering with technical excellence and uncompromising quality standards. This dedication is evident in everything we do.
High achievers are welcome.
Medical engineering is an industry of the future. In a field marked by rapid developments and short innovation cycles, the best guarantees for sustain...able success are committed, creative, team-oriented specialists, and outstanding leadership. If you are passionate about computer science, engineering or the natural sciences and enjoy developing new ideas, you´ve found the right place.Are you interested?
Take a look at our website www.biotronik.com/careers
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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