Start-Up Specialist II

Wayne, PA

Job Summary

The Start-Up Specialist II is responsible for providing operational support across the department so that required services are delivered on time and within budget.

Summary of Essential Job Functions

  • Set up and maintain project related systems, dashboards and document templates
  • Coordinate mass mailings/faxes, distribute surveys, documents and information to sites and clients as required and follow-up in accordance with study/project requirements
  • Negotiate simple contractual documents with investigator sites (i.e. CDAs) as determined by the Start-Up Lead or Senior Start-Up Lead
  • Perform quality control reviews of project documents (e.g. investigator survey, CDA, CV, medical license)
  • Upload investigator site documents to client specified locations (i.e. client e-TMF, SharePoint workspace, etc…)
  • Serve as primary point of contact for investigator sites, either personally or through a shared mailbox.
  • Work with the Start-Up Lead or Senior Start-Up Lead to create, run, distribute, and maintain required project reports
  • Assist in the preparation for regulatory and/or sponsor audits
  • Other duties as assigned



  • Analytical Thinking: Tackle problems by using a logical, systematic, sequential approach
  • Attention to Communication: The ability to ensure that information is passed on to others who should be kept informed
  • Fostering Teamwork: The ability and desire to work cooperatively with others on a team
  • Customer Orientation: The ability to demonstrate concern for satisfying one’s external and/or internal customers
  • Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it
  • Oral Communication: The ability to express oneself clearly in conversations and interactions with others
  • Thoroughness: Ensuring that one’s own and others’ work and information are complete and accurate
  • Written Communication: The ability to express oneself clearly in business writing

Supervisory Responsibilities

This position does not have responsibility for managing people.


Minimum Experience Requirements

  • A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree
  • Two (2) years of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
  • Basic knowledge of the clinical trial process and ICH guidelines and FDA, IRB/IEC regulations preferred
  • Study start-up support experience in a clinical or regulatory operations capacity

Skill Requirements

  • Ability to handle multiple tasks to meet deadlines in a dynamic environment
  • Ability to motivate self when working under pressure to meet deadlines
  • Good communication skills, both written and oral
  • Multi-language skills are a plus
  • Strong organizational, documentation, and interpersonal skills as well as a willingness to work in a team-oriented environment
  • Strong analytical and problem solving skills
  • Willingness to be flexible as the business requires

Apply Online

Location: Wayne PA