Senior Regional Site Manager - KS/MO in Overland Park, KS at Apex Life Sciences

Date Posted: 5/29/2018

Job Snapshot

Job Description


POSITION SUMMARY:

  • The Senior Regional CRA 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.
  • Conducts all monitoring visits in accordance with standards.
  • Exercises responsibility across multiple projects and therapeutic areas.
  • Interfaces with clinical investigators, other site staff and personnel in order to carry out this responsibility.
  • Accountable for site management and data quality for each assigned site. 
  • This is a regional home based position. 

RESPONSIBILITIES: 

Conduct the following monitoring visits according to applicable 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), and 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. 

Additional responsibilities:

  • Submission of MVRs in CTMS. 
  • Submission of site regulatory documents to the TMF 
  • Retrieval of all paper case report forms (if applicable). 
  • Maintenance of calendar. 
  • Submission of weekly time and expense reports. 

QUALIFICATIONS: 

  • Bachelor’s degree required or a medical/healthcare certification/license, including RN, PA, or RPh. 
  • 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 preferred  
  • 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 be open to 50% overnight travel on average

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.