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Remote, Senior Regional Site Manager/Monitor with CNS and GI Therapeutic Area

Alpha Consulting Corp. Corona, CA Contractor
$0.00 - $70.27 / hour
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PAY RATE: $70.27/hr. W2

Project Description:
The Senior Regional Site Manager (Senior RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected. The Senior RSM conducts all monitoring visits in accordance with Client standards. The Senior RSM exercises responsibility across multiple projects and therapeutic areas. The Senior RSM interfaces with clinical investigators, other site staff and Client personnel in order to carry out this responsibility. The Senior RSM is completely accountable for site management and data quality for each assigned site. In addition, the Senior RSM may hold other assignments, such as Lead Site Manager, Global Site Management Operations Subject Matter Expert (SME), Contract Research Organization (CRO) Oversight Representative, or any other project assigned by Global Site Management Operations management.
The Senior Regional Site Manager is a regional home based position.
  • Conduct the following monitoring visits according to applicable Client SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines as follows:
    • Site Qualification Visits (SQVs)
    • Site Initiation Visits (SIVs)
    • Interim Monitoring Visits (IMVs)
    • Remote Monitoring Visits (RMVs)
    • Close-out Visits (COVs)
  • Manage all site activities for assigned sites including:
    • Partnering with sites to ensure recruitment goals are met.
    • Assisting sites with operational needs (e.g. vendor activities, site payment).
    • Primary contact for all issues that arise with sites.
  • Communicate site status and monitoring activities, as follows:
    • Submit monitoring visit reports (MVRs) for all monitoring visits conducted.
    • Send follow-up letter to Principal Investigator summarizing visit conduct and all action items.
    • Contact the Regional Operations Manager (ROM) and Project Lead (PL) regarding significant site conduct issues.
    • Complete GXP Compliance audit responses in conjunction with ROM and PL.
  • Meet all departmental timelines and deliverables for the following activities:
    • Submission of MVRs in IMPACT/CTMS.
    • Submission of MVRs to the TMF.
    • Freezing of all electronic case report forms.
    • Retrieval of all paper case report forms (if applicable).
    • Maintenance of calendar.
    • Submission of weekly time and expense reports.
  • Attend and participate in all relevant meetings, as follows:
    • Annual Global Site Management Operations meeting.
    • Regional Global Site Management Operations meetings, as scheduled.
    • Investigator Meetings for all assigned studies.
    • Regional Site Manager teleconferences for all assigned studies.
    • Regular regional teleconferences.

In addition to the primary responsibilities of site monitoring, the Senior Regional Site Manager may also hold specialized roles in one or more of the following areas:
  • As a Lead Site Manager:
    • Review and provide input to protocols and Case Report Forms.
    • Act as primary author for Protocol-Specific Monitoring Plan.
    • Present monitoring plan and monitoring expectations at the Investigators meeting.
    • Maintain SharePoint and/or Global Site Management Operations portal with study-specific information.
  • As a Global Site Management Operations Subject Matter Expert (SME):
    • Present at regional and annual meetings for Global Site Management Operations.
    • Present components of Global Site Management Operations Orientation to newly hired Global Site Management Operations personnel.
    • Assist in development and maintenance of the Global Site Management Operations Orientation program.
  • As an Oversight Representative on Client projects managed by CROs:
    • Participate in regular meetings between Client and the CRO Conduct Monitoring Oversight Visits to clinical research sites.
    • Review and provide input to protocols, Case Report Forms, and monitoring plans.
    • Review Monitoring Visit Reports and provide feedback.
  • The Senior RSM is also responsible for any other projects assigned by Global Site Management Operations management.

Required Skills:
  • Allied Health Professions degree (PA, RN, RPh), or four-year life science degree.
  • Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization (5 years preferred).
  • Experience working in more than one therapeutic area.
  • Familiar with Electronic Data Capture preferred.
  • Experience with Risk Based Monitoring highly desired.
  • Strong knowledge, understanding, and application of monitoring SOPs and Good Clinical Practice.
  • Good working knowledge of the drug development process.
  • Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook.
  • Must possess excellent skill/ability in the following:
    • Written and Oral Communication
    • Planning and Organizing
    • Promoting Innovation
    • Decision Making, Judgment, and Problem Solving
    • People Relationships, Influencing Others, Motivating Others, Team Building
    • Initiative and Accountability
    • Possessing management skill/ability in the following is a plus:
    • Maintaining activities and Coordinating activities
    • Training new team members
  • Ability to communicate clearly with a variety of professional and medical personnel.
  • Strong ability to work independently toward completion of assignments.
  • Skilled at teaching and training others.
  • Must work effectively and efficiently in a home-based office environment.
  • Will maintain a fully functional home office (high speed internet connection, office phone, copier, etc.).
  • May potentially travel overnight an average of 50%.
  • May be required to lift more than 25 pounds, in association with travel requirements.
  • Must maintain a credit limit that would support routine business travel expenses.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: [ Link removed ] - Click here to apply to Remote, Senior Regional Site Manager/Monitor with CNS and GI Therapeutic Area



Recommended skills

Ich Guidelines
Clinical Research
Good Clinical Practices (Gcp)
Electronic Data Capture
Clinical Trial Management Systems
Clinical Trials
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