Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

 

Clinical Trials Support Specialist

Job #18-13A

 

Mapp Biopharmaceutical Inc., is a biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases.  The Clinical Trials Support Specialist will provide administrative, operational and clinical trials support to the Clinical Operations Team.

Basic Qualifications:

  • Bachelor's Degree or equivalent
  • Three years of experience with US Clinical Trial Coordination and/or Support
  • Willing and capable to assist with multiple projects and responsibilities
  • Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Previous experience with US clinical trial support
  • Ability to work remotely and effectively with a virtual team
  • Understanding of FDA, GCP, ICH and/or other regulatory requirements that may impact global clinical studies and clinical trial management
  • Ability to engage in domestic travel to the degree appropriate to support the team
  • Strong communication, interpersonal, teamwork, organization and problem-solving skills
  • Excellent written and verbal communication skills

Preferred Qualifications:

  • Experience with trial requiring parenteral administration of drug
  • Experience with support of clinical trials outside of US
  • Experience with supporting clinical supply chain management

Responsibilities

  • Assists with scheduling internal and external team meetings
  • Maintains clinicaltrials.gov listings
  • Assists with formatting and compiling Clinical Study Reports
  • Assists in developing and maintaining clinical training documents in PowerPoint
  • Assembles and provides minutes for internal and external clinical project meetings, including meetings with clinical vendors, funding agencies
  • Creates, updates and maintains databases of vendors, subcontractors, clinical sites, and other Mapp partners
  • Formats clinical documents prior to submission to regulatory agencies
  • Maintains version control of all clinical documents and project plans
  • Assists with set up and maintenance of Mapp electronic Trial Master File
  • Contributes to monthly and annual progress reports to funders and other stakeholders, as required
  • Assists with coordinating, scheduling and tracking shipments of clinical supplies to clinical sites both domestically and internationally which includes compiling import/export documentation and end user information
  • Manages Clinical Operations document sharing site
  • Obtains and presents multiple quotes and/or price estimates for clinical supplies in support of active clinical trials

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunitiy to work remotely. Less than 5% domestic and international travel is required. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
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