• PRA Health Sciences
  • $57,440.00 -80,040.00/year*
  • Lowell , MA
  • Scientific Research
  • Full-Time
  • 824 Bridge St

Responsibilities

What will you be doing?

As a Global CPA, you will be responsible for assisting the Global Project Manager within a Trial Operations Group dedicated to a Therapeutic Area Business Unit in a specific geographical site by performing routine administrative responsibilities and/or routine operational tasks associated with the coordination of clinical trials. A CPA may be given primary and back-up administrative support responsibilities only or a combination of general administrative support and operational administrative responsibilities depending on the size of the team/workload capacity, CPA's skill level, and business needs. A CPA providing administrative support is responsible for knowing and complying with current processes, policies and standards. Ability to maintain a high level of confidentiality is critical.

Responsibilities may include but are not limited to:

  • Travel arrangements Expense Report Processing includes T&E tracking in designated electronic system(s)
  • Meeting / videoconference arrangements
  • Office Supply Ordering
  • IT / maintenance issues (copiers, phones, computers, etc)
  • Time-off (Vacation / Sick / Personal Days) Tracking
  • Out-of-office Telephone Coverage for TLs and GLs
  • Serves as Learn Program Administrator
  • Update various department lists & org chart
  • Mailings, photocopying & faxes
  • Other central corporate systems administrator roles as determined
  • Administrative Support Responsibilities Conducted in Accordance with Processes, Policies and Standards
  • Travel arrangements
  • Expense Report Processing includes T&E tracking in designated electronic system(s)
  • Meeting / videoconference arrangements
  • Office Supply Ordering
  • Preparation of CTT Minutes
  • Formats and/or creates informational study documents (eg, newsletters, FAQs, etc)
  • Coordinates preparation and distribution of ancillary trial supplies with internal or external partners
  • After adequate training & with supervision: Coordinate with Study Vendors or co-development partners for delegated tasks (eg, IVRS, e-learning, central laboratory, recruitment/retention).
  • After adequate training & with supervision: Coordinates the logistics of CRU training and Investigators' meetings (face to face or net-meeting): registration forms, invitations, slides and training materials OR liaises with a meeting planner.
  • Filing
  • Collection, maintenance and archiving of essential study documents (electronic and paper) and tracking oversight in collaboration and with Record Manager
  • CSR Appendices assist in preparation and coordination
  • Qualifications

    What do you need to have?

    Education: Undergraduate degree or its international equivalent in clinical, science, or health related field

    Skills:

  • Read, write, and speak fluent English; fluent in host country language required
  • Minimum of 2 years of related experience
  • Experience with PC-Windows, word processing, and electronic spreadsheets required.
  • Knowledge of ICH and local regulatory authority drug research and development regulations required.
  • Clinical trials support or pharmaceutical industry experience required.
  • Familiarity with Windows-based computer applications (eg, MS EXCEL, ACCESS and Powerpoint) and working in clinical trial management systems (eg, IMPACT)
  • Good interpersonal and communication skills (verbal and written) including ability to maintain a high-level of confidentiality
  • Detail-oriented, ability to handle multiple tasks efficiently and effectively, and excellent organizational skills important
  • Ability to work effectively in a team
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

  • Associated topics: aseptic, biopharmaceutical, dietetic, immunology, metabolism, microbiological, pharmaceutical, therapeutic, therapy, toxicologist

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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