Research Specialist - Regulatory/Compliance

CHEManager International; Pittsburgh (Allegheny County); Hybrid; USD 75.000 - 110.000; Vollzeit

Zusammenfassung

CHEManager International seeks a Research Specialist - Regulatory/Compliance to join the Sponsored Clinical Trials & Partnerships Team in Pittsburgh. The role centers on pre-award activation of industry-sponsored trials by preparing and managing regulatory documentation for initial approvals and ongoing compliance.

You will collaborate with investigators, sponsors and institutional stakeholders to ensure regulatory integrity through the study lifecycle, and support post-award activities.

Qualifikationen

• 3 years of experience in industry clinical trials or research operations.
• 2 years of experience in regulatory or pre-award programs is strongly preferred.
• Knowledge of clinical research regulations (FDA, OHRP) or related exp is essential.
• Excellent analytical, organizational and communication skills.
• Ability to work independently and in a team; certification is a plus.

Aufgaben

• Prepare and review pre-award regulatory documents (ICF) in compliance with policies and regulations.
• Lead institutional review and negotiation of ICF language with industry sponsors for new protocol submissions and amendments.
• Guide study teams to submit approved ICFs to IRBs in accordance with regulations.
• Provide guidance on regulatory materials for Expanded Access and Compassionate Use studies while ensuring FDA compliance.
• Maintain submission records and tracking to support startup timelines and activation metrics.
• Provide regulatory guidance to investigators, sponsors, SCTP staff during startup.
• Post-award: ensure ongoing compliance with IRB approvals, amendments, and renewals per regulations.
• Support regulatory operations for SCTP and related systems.
• Identify process improvements in the pre-award workflow and contribute to quality initiatives.

Kenntnisse

Analytical skills

Organizational skills

Communication skills

Teamwork

Ausbildung

Bachelor's degree in health related field

Jobbeschreibung

PurposeThe Research Specialist - Regulatory/Compliance focuses is part of the Sponsored Clinical Trials and Partnerships Team. The role focuses on pre-award activation of industry-sponsored clinical trials by preparing and managing regulatory documentation required for initial approvals and ongoing compliance and integrity. This role ensures the regulatory integrity of assigned studies from pre-award through study closure, working closely with investigators, sponsors, and institutional stakeholders to meet all applicable requirements.

PurposeThe Research Specialist - Regulatory/Compliance focuses is part of the Sponsored Clinical Trials and Partnerships Team. The role focuses on pre-award activation of industry-sponsored clinical trials by preparing and managing regulatory documentation required for initial approvals and ongoing compliance and integrity. This role ensures the regulatory integrity of assigned studies from pre-award through study closure, working closely with investigators, sponsors, and institutional stakeholders to meet all applicable requirements. Please note that this position is in-office 3 days per week. Must be legally authorized to work in the United States, without requiring, now or in the future, sponsorship for employment visa status. UPMC does not offer any type of sponsorship (H-1B, permanent residence, etc. ) UPMC does not participate in STEM OPT. Responsibilities

• Prepare and review pre-award regulatory documents, namely informed consent forms (ICF), in compliance with UPMC policies/language, sponsor requirements, and 21 CFR Parts 50, 54, 56, 312, 812, 45 CFR 46, and ICH-GCP E6.
• Conduct and lead institutional review and negotiation of ICF language with industry sponsors for new protocol study submission and study amendments.
• Guide study teams to properly submit approved ICFs to Institutional Review Boards (IRBs) in accordance with 21 CFR Part 56 and institutional procedures.
• Provide guidance to study teams by reviewing and approving regulatory materials for Expanded Access and Compassionate Use studies (sINDs, HUDs, EAPs, etc.), ensuring compliance with 21 CFR 312 and FDA guidance, while supporting timely activation.
• Maintain accurate submission records and tracking systems to support pre-award decision-making, study startup timelines, and study activation metrics.
• Provide regulatory guidance and act as a subject matter expert for investigators, sponsors, SCTP consultants, SCTP contractors, and study teams during the startup phase of clinical trials.
• Post-award:
  • Assist study teams in ensuring ongoing compliance by confirming industry-sponsored trials are conducted under the most current IRB approvals, amendments, and renewals, per 45 CFR 46
  • Support regulatory operations for UPMC CTMS.
  • Identify process improvement opportunities in the pre-award regulatory workflow and contribute to quality initiatives within the Sponsored Clinical Trials & Partnerships (SCTP) team.
  • Support organizational compliance by ensuring all applicable FDA, OHRP, NIH, and HIPAA requirements are met prior to study initiation and throughout the lifecycle of assigned studies.
  • Assists SCTP management with development and maintenance of SOPs and guidance documents.

Qualifications

• Bachelors degree in health related field.
• 3 years of experience in industry clinical trials or research operations.
• 2 year of experience in regulatory or clinical trial pre-award programs strongly preferred.
• Knowledge of clinical research trials regulations, (i.e., Office of Research and Human Protections (OHRP) and Food and Drug Administration (FDA) is essential. or 1+ years' experience in drug development, regulatory or clinical operations functions is strongly preferred.
• Excellent analytical skills with attention to detail.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Ability to work both independently and as part of a team.
• Clinical Research Professional Certification or related certification is a plus.

Licensure, Certifications, And Clearances

• Act 34

UPMC is an Equal Opportunity Employer/Disability/Veteran