What are the responsibilities and job description for the Clinical Research Associate - Level 3 position at NSABP Foundation, Inc.?
The NSABP Foundation has an opening for Clinical Research Associate - Level 3. This is a hybrid position located in Pittsburgh, PA requiring 3 days in the office and 2 days remote work.
PURPOSE
The role supports breast and colorectal cancer clinical trial operations with all efforts directed toward accrual to NSABP protocols. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. This team member is viewed as an expert regarding the workings of clinical trial operations. Team members in this role collaborate across internal departments and function as the external “face” of the NSABP Foundation to external partners.
ESSENTIAL FUNCTIONS
- Actively participate in study start-up activities. Examples of frequent activities include participation in partner meetings, study timeline start-up development, site selection, Principal Investigator review.
- Assist with site activation including document collection, ICF review, site access to study platforms, facilitate site questions.
- Facilitate team huddles to assess, plan, review and prioritize activities to ensure timely site activation.
- Participate in study specific training as required.
- Develop relationships with site staff and NSABP monitors.
- Act as a liaison among NSABP, site staff, external partners.
- Track study metrics developed by either NSABP or external partners.
- Assist with identifying metrics that require additional focus and developing an action plan.
- Develop and implement recruitment strategies to ensure accrual targets are met.
- Develop awareness of site visits by monitors. These include site initiation visits, interim monitoring visits, close out visits.
- Follow Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines.
- Function as a resource for specific Study Start-Up Plans, Clinical Monitoring Plan, Roles and Responsibilities grid and other study-specific documents
- Collaborate with clinical research organizations and centralized services such as central laboratories.
- Collaborate with data management regarding CRF development.
- Act as a resource to sites and investigators.
- Perform other job-related duties as assigned.
OTHER RESPONSIBILITIES
- Knowledge of randomized clinical trials principles and procedures.
- Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials.
- Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management.
EXPERIENCE/SKILLS
- Bachelor’s degree required.
- Minimum of 3 years' experience as a CRA required.
- Familiarity with electronic TMF, EDC and CTMS systems required.
- Strong verbal, written and organizational skills with a team-oriented approach.
- Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
- Proficiency in Microsoft Office Suite
HYBRID POSITION
- This is a hybrid position consisting of 2 days of remote work (Wednesday and Friday) and 3 days onsite in our office in Pittsburgh, PA (Monday, Tuesday and Thursday).