1 Clinical Research Site Monitor Job in Pittsburgh, PA
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Clinical Research Site Monitor
$67k-89k (estimate)
Full Time | Civic & Environmental Advocacy
3 Weeks Ago
NSABP Foundation is Hiring a Clinical Research Site Monitor Near Pittsburgh, PA
Job DescriptionPURPOSEThis is a contracted role intended to be the “external face” of the organization at NSABP sites, with principal investigators and research staff. This role functions as a bridge from site operations to NSABP operations to ensure data integrity, patient safety and regulatory compliance. This role supports breast and colorectal cancer research and the successful execution of clinical protocols at multiple sites while ensuring compliance with regulatory and contractual agreements.
Essential Functions
This position may require up to 85% travel.
Essential Functions
- Participates in the development of the overall clinical plan, including site initiation visits (SIV), interim monitoring, site management activities and close-out visits, including investigational product management.
- Documents activities using templated communication forms.
- Compliant with the Clinical Monitoring Plan (CMP) for each study.
- Acts as a resource to sites and investigators to triage site questions, respond to queries, identify gaps, and assist with mitigation planning/implementation.
- Collaborates with clinical research organizations and centralized services such as clinical laboratories.
- Participate in study specific training as required.
- Collaborates with data management regarding CRF development, completion, identification of deviations and query management.
- Participates in identifying potential investigators and clinical sites.
- Ensures the security and compliance of all documents related to active and archived projects.
- Performs investigational product inventory, reconciliation, storage and security assessment, dispensing practices, and documentation.
- Reviews Investigator Site File (ISF) with Trial Master File for accuracy, completeness, and timeliness.
- Verifies informed consent process and its documentation.
- Collaborates with NSABP Operations staff regarding site and study management issues.
- Coordinates protocol review and approval process, including submissions to regulatory agencies.
- Collects and processes regulatory documents and may review them for content and accuracy.
- Compliant with specific study scope of work.
- Adheres to contractual signed tasks.
- Compliant with site data integrity process including background checks and EMR access policies.
- Attends all scheduled Operations meetings or study specific meetings.
- Performs other job-related duties as assigned.
- Knowledge of randomized clinical trials principles and procedures.
- Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials, including ICH-GCP.
- Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management.
- Bachelor’s degree required.
- Strong software literacy and high degree of comfort in working with multiple software programs.
- Experience with clinical trials preferred.
- Familiarity with electronic TMF, CRF and CTMS systems preferred.
- 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.
This position may require up to 85% travel.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Civic & Environmental Advocacy
SALARY
$67k-89k (estimate)
POST DATE
06/01/2024
EXPIRATION DATE
07/31/2024
WEBSITE
nsabp.org
HEADQUARTERS
PITTSBURGH, PA
SIZE
50 - 100
TYPE
Private
CEO
RANDY ANSELMINO
REVENUE
$10M - $50M
INDUSTRY
Civic & Environmental Advocacy
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