Clinical Research Associate - Level 3 Job at NSABP Foundation Inc., Pittsburgh, PA

WGFHRWo5MTNWaHpHdk53akpJcmdKcHRySHc9PQ==
  • NSABP Foundation Inc.
  • Pittsburgh, PA

Job Description

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

This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors.

ESSENTIAL FUNCTIONS

  • Actively plans, executes and assesses performance of activities across the life span of study.
  • Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review.
  • Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise.
  • Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep.
  • Completes required trainings with appropriate documentation.
  • Develops relationships with site staff and NSABP monitors.
  • Acts as a liaison for NSABP, site staff and external partners.
  • Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics.
  • Responsible for providing regular metrics assessment to leadership team.
  • Identifies key metrics with poor performance and develops an action plan to remediate the issue.
  • Develops and implements recruitment strategies to ensure accrual targets are met.
  • Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP).
  • Reviews and approves itineraries to ensure CMP compliance and associated expense reports.
  • Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines.
  • Develops, writes and implements Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents.
  • Collaborates with clinical research organizations and centralized services such as laboratories.
  • Collaborates with data management regarding CRF development and UAT testing.
  • Acts as a resource to sites and investigators.
  • Accompanies study monitors within 3 months of onboarding to confirm that the CMP is implemented accurately, and that PI/site needs are met.
  • Reviews SIV and monitoring reports to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements.
  • Supports study monitors with resolution of significant site issues.
  • Performs 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.
  • Prior CRA experience required.
  • Research certification strongly preferred
  • Prior experience at CRO strongly preferred.
  • Familiarity with electronic TMF, EDC and CTMS systems required.
  • Strong verbal, written and organizational skills with a team-oriented approach required.
  • 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).

The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.

Job Tags

Interim role, Work at office, Remote work,

Similar Jobs

Behring Co.

Senior Financial Analyst - Real Estate Investments & Development Job at Behring Co.

About Behring Capital Behring Capital is a vertically integrated real estate private equity firm, pioneering a bold vision for how urban mixed-use ecosystems are built, financed, and operated. As we scale, were assembling a high-performance team that blends analytical...

Airbus Americas, Inc.

Technical Project Manager Job at Airbus Americas, Inc.

 ...Airbus US* * Manufacturing Facility is looking for a Technical Program Manager to join our FAL based in *Mobile, AL.*The Technical Program Manager will be responsible for leading a portfolio of projects & programs in various technical areas related to commercial aircraft... 

STEAM BEANS, INC

STEAM BEANS- Education Internship/ Volunteer Position Job at STEAM BEANS, INC

 ...STEAM Beans is seeking passionate, dedicated, and future-focused internship/volunteers who are eager to empower and uplift African American...  ...STEAM Beans is a dynamic Science, Technology, Engineering, Arts, and Math (STEAM) education program designed specifically for African... 

Arizona Autism United

Board Certified Behavior Analyst (BCBA) - Clinical Family Coaching Job at Arizona Autism United

 ...high quality direct services and supports to children and families in our community. We are looking for a talented and passionate BCBA to join our Clinical Family Coaching team andhelp advance our mission of helping as many families as possible with individualized... 

Freeman+Leonard

Graphic Designer Job at Freeman+Leonard

Job Description Freeman+Leonard is searching for a fulltime Graphic Designer for an in-house agency in Fort Worth, Texas. This is a fully onsite position, local candidates only. Position Summary: ~ The Graphic Designer is responsible for creating and executing...