Regulatory Affairs Associate

Advancing Care Through Innovation

Come Join Panoramic's Science Divison!

Position is remote and Monday - Friday; 8am-5pm

To learn more about Panoramic Science visit: https://panoramichealth.com/clinical-research/

The Regulatory Affairs Associate, in concert with the Regulatory Affairs Lead, is accountable for achieving successful delivery of clinical trial activities across a multi-site clinical research network by meeting regulatory and quality requirements. Depending upon study scope, the Regulatory Affairs Associate may manage multiple ongoing clinical trials and projects.

Responsibilities Include

• Creates study in electronic system
• Files IRB submissions, IRB reviews, and study documents submitted to IRB in Investigator Site File (ISF) for each site/study for site/monitor review/collection
• Files other regulatory documents and study documents in ISF for each site/study for site/monitor review/collection
• Prepares ISF for Site Initiation Visit (SIV)
• Creates electronic Delegation of Authority Log for each study, updates it as needed, routes for signature, and files in ISF
• Creates and maintains staff profiles in electronic system with Delegation of Authority Log
• Maintains and files credentials in ISF including updating credentials spreadsheet
• Prepares and maintains ISFs for Interim Monitor Visits (IMVs) and Close-Out Visits (COVs), including communicating with the monitor/CRA and site CRC to ensure outstanding issues have been resolved, updating the DOA Log, finalizing the Monitor Visit Log, submission of IRB closure completed, and filing all finalized documents in the ISF
• Prepares ISF for audits as required
• Completes Feasibility Questionnaire population as required and update Studies Tracker accordingly
• Creates study slides and drafts study collateral documents
• Ensures seamless Pre-Award and Post-Award hand-off
• Maintains vendor list per site/geographic location and proactively review protocols for vendor requirements
• Assists with scheduling site visits (PSVs and SIVs) as assigned
• Perform other duties and responsibilities as required, assigned, or requested.
  
  
  

Qualifications

• Bachelors’ degree in Business or Health Science preferred or equivalent experience
• 2–4 years of professional experience in clinical research, preferably in a regulatory environment
• Background in regulatory affairs and compliance specific to clinical research protocols and standards.
• Strong administrative capabilities and proficiency with computer applications preferred.
• Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations.
• Requires excellent interpersonal and communication skills.
• Requires flexibility, excellent organization skills, and attention to detail
• Must be able to multitask and able to handle a high volume of multiple studies.
  
  
  

The Company is committed to the principles of equal employment. We are committed to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment which is free of harassment, discrimination, or retaliation because of age, race, color, national origin, ancestry, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed servicemember status, or any other status protected by federal, state, or local laws. The company is dedicated to the fulfillment of this policy in regard to all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment

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