Clinical Affairs Safety Associate II-III

Job ID
19395
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.


The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Clinical Safety Associate II-III. The Clinical Safety Associate (CSA) functions as an internal subject matter expert (SME) providing consultation on protocol safety data and data management. The CSA performs safety data monitoring activities on phase I-III safety trials. The CSA monitors clinical trial data for completeness, accuracy, protocol, safety and regulatory compliance.

Responsibilities

The Clinical Safety Associate (CSA) participates in protocol development activities to ensure required safety-related data are adequately represented and captured. The CSA will monitor clinical trial safety data for compliance in reporting, completeness, and accuracy. The CSA serves as the primary liaison between the Protocol Safety Review Team (PSRT) or the Independent Safety Reviewer (ISR) for safety monitoring activities. The CSA will actively monitor study data throughout the life of the trial for safety compliance and data accuracy.


The CSA functions with minimal supervision and demonstrated decision making ensuring that the protocol requirements and clinical data safety needs are met.

 

Level II

  • Participate in protocol development activities, including working with other protocol team members to develop clinical trial safety monitoring and reporting strategies and tools.
  • CSA to facilitate reviews with the Protocol Safety Review Teams (PSRT) and/or Independent Safety Reviewers (ISR) to ensure appropriate clinical safety report design and representation of safety related data.
  • Monitor and work with sites, to ensure clinical data completeness, accuracy and alignment with regulatory reporting requirements.
  • Function as an active member of the PSRT, facilitating PSRT data reviews, including preparing, reviewing and distributing safety reports.
  • Facilitate safety reviews for study ISRs.
  • Provide ongoing consultation on protocol safety issues to protocol teams, network partners, sponsors and internal partners.
  • Reconcile AE data in the clinical database and SAE/EAE data in the safety database, work with collaborators to resolve discrepancies, and complete data reconciliation reporting requirements.
  • Conduct clinical trial clinical data closeout activities, to include resolution of all outstanding safety queries, facilitating final safety reviews for PSRTs/ISRs and finalizing all reconciliation activities, completing study closeout checklists.
  • Manage safety issues identified by the PSRT and/or Safety Monitors to and/or from sites. Obtain clarification and additional information as necessary.
  • Coordinate modifications of safety reports & safety monitoring system per PSRT or ISR request or protocol modification.
  • Perform clinical review and evaluation of received reference ranges from the labs in accordance with our Standard Operating Procedures (SOP) processes.
  • In collaboration with internal partners, safety physicians and PSRT/ISRs, query sites for clarification of clinical data, and work with sites to resolve these queries.
  • Work in collaboration with internal and external partners to meet protocol milestones such as SMC, DSMB, and FDA reporting deadlines.
  • Send timely notification to the safety physicians and/or PSRT regarding safety events that meet specific criteria, as agreed upon per protocol requirements.
  • Mentor and train junior CSA staff.
  • Conduct clinical safety training for external and internal staff
  • Assist in the authoring and maintaining Standard Operating Procedures (SOPs).
  • Participate in regulatory, pharmacovigilance and safety training to remain up to date on standard industry practices.
  • Conduct all job duties according to appropriate SOPs and within the context of Good Clinical Practice (GCP) guidelines.

 
Level III

  • All Level II responsibilities
  • Participate in SCHARP process improvement projects as the SME for Safety.
  • Identify corrective and preventative actions (CAPA) to non-compliance issues.
  • Lead efforts in preparing and responding to Regulatory Agency inspections, external and internal audits.
  • Development and implementation of protocol safety management plans for safety monitoring and reporting.
  • Lead team effort to author and maintain SOPs for safety monitoring practices.
  • Subject Matter Expert Responsibilities:
    • Function as primary point of contact on clinical data monitoring process and requirements for internal and external partners.
    • Function as primary point of contact on study clinical data implementation and closeout activities for internal and external partners.
    • Develop training resources and activities for Clinical Safety Associate staff.

Qualifications

Minimum Qualifications

Level II

  • Healthcare Professional Degree  - RN/BSN/MSN, NP, PA, RPh/PharmD/PhD/B.Pharm or MD.
  • Three years clinical trial experience required
  • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data

 

Level III

  • Healthcare Professional Degree - RN/BSN/MSN, NP, PA, RPh/PharmD/PhD/B.Pharm or MD
  • Five years clinical trial experience required
  • Familiarity with GCP, ICH and FDA requirements as they apply to clinical data
  • Experience in Safety Reconciliation activities

 


Knowledge, Skills and Experience:

  • Familiarity with clinical trials safety data collection practices, clinical data and adverse event reporting and regulatory requirements strongly preferred
  • Excellent written and verbal communication skills
  • Position requires a high level of attention to detail and organization
  • Strong, demonstrated technical skills (EDC systems, Microsoft Excel, Word, PowerPoint), Medidata RAVE desired
  • Ability to work independently and take initiative in a dynamic environment


A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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