Senior Clinical Research Associate - Medical Device - East or Central

Overview

The Sr CRA and is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.

Responsibilities

Sr CRA and is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.

• The CRA will support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.

• The CRA will expand his/her responsibilities as directed by the Clinical Research Manager [CRM] or Clinical Project Leader [CPL] to include fostering the development of the monitoring program and/or facilitating the objectives of the clinical project teams. The CRA will also assist the CRM/CPL, as directed, in the training, mentoring and supervision of CRAs, assisting in co-monitoring of sites and in completing special projects and assignments to further advance the monitoring program and its contributions to the clinical research department.

JOB FUNCTIONS/RESPONSIBILITIES

• Track subject enrollment and identify R&R issues, maintain regular communication w/site staff. Document and communicate study site progress and issues/concerns to the project team.

• Assist other CRAs with study site issues/concerns/audits with the investigator and independently offer resolution strategies, documenting follow-up activities/outcomes.

• Lead or facilitate collaborative CRA efforts to meet company objectives by organizing/managing special data collection efforts, present or set up task force, as directed by CRM/CPL.

• Follow the Site Management / Ownership / Partnership model to monitor multiple Phase II, III & IV clinical trial sites, across therapeutic areas. Independently schedule and prioritize workload to meet projected deadlines.

• Provide adequate reporting and tracking of AEs, protocol deviations and subject status.

• Provide the following support as directed by the CRM/CPL: assist in field monitoring training; conduct and observe site visits during training period; offering experienced counsel on issues related to SOPs, regulations and resolution tactics for site issues/concerns.

• Build regional territory by identifying and maintaining contact with potential (near or long term) research investigators.

• Expand understanding of regulations governing clinical research, beyond FDA regulations and ICH/GCP guidelines, (e.g. international regulatory procedures or high level of proficiency in a specific area, e.g. AE reporting) so as to be a resource for the CRA team.

Qualifications

• EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

  In-depth knowledge of FDA regulations and ICH/GCP guidelinesExcellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems

  Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor

  Ability to independently resolve site or study related issues Self motivated; detail oriented; team player; flexible

  Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas

  Excellent organizational and time management skills

  Function effectively with high degree of personal accountabilityACRP CCRA or SoCRA certified

  EDUCATION REQUIREMENTS

• Minimum 4 years industry experience as a CRA, or equivalent; experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy) or pre-clinical area (e.g. pharmacology, toxicology) desired.

• Medical Device experience 

• Health related background and BS Degree required.

  Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

  At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

  ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us kno