To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

What are the top 3-5 skills, experience, or education required for this position:

• Required: Bachelor's degree in science or relevant field of study
• Required: 3-5 years of US site management & monitoring experience which must include non-interventional studies and remote monitoring/logic check experience. Note: both onsite and remote monitoring experience is required.
• Required: Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strongly preferred: Migraine or Migraine/gepant study experience. Neuroscience and pain management experience is a secondary preference.
• Strongly preferred: Experience with site-specific central IRB submissions/Advarra

Job Description:

• Monitors activities conducted by study sites as they relate to non-interventional studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard
• Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Provides timely, and complete monitoring reports including action items and follow-up.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies by applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
• Ensures audit readiness at assigned sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations.
• Manages site-specific central IRB submissions and approval, including tracking
• Maintenance of site files within the TMF.
• Manages site-specific updates to CTMS systems
• Site feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an ongoing basis. to assist in the placement of planned studies with qualified investigators/sites.

Qualifications:

• Bachelor's degree in science or relevant field of study
• 5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience. Note: both on-site and remote monitoring experience is required.
• Experience with Migraine or Migraine/gepant trials preferred. Neuroscience and pain management experience is a secondary preference.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
• Ability to address study-related clinical site issues with appropriate guidance and initiate and communicate corrective action as indicated.
• Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.