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Clinical Project Coordinator


Waltham, Massachusetts
  • Business Development/Operations
  • Healthcare
  • Coordinators
  • Monitoring
  • Project Management
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  • Research Salary

Job Details

At CROMSOUCE, the Project Coordinator is working directly with the Project Managers on a variety of clinical trials. As a PC, you must have some experience working in a similar role – supporting the management of clinical projects. The PC manages the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines and other applicable regulations.

Main responsibilities include:

  • Manages all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.)
  • Manages the correct development of the clinical project, interacting with the Sponsor and the Investigators under the supervision of the PM/SPM
  • Keeps him/herself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects he/she will be assigned
  • Should be knowledgeable, following appropriate trainings, in the application process for clinical studies, in force in the country (ies) of work. Accordingly he/she can be required to provide updates on the topic, whenever relevant
  • Collects and manages study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
  • May act as Technical Specialist supervising the projects within specific therapeutic/technical areas under the supervision of the PM and only after appropriate training
  • Assures the proper timelines of the assigned projects
  • Coordinates the Clinical Research Associate (CRAs)/Clinical Monitors (CMs) activity, ensuring the compliance with the ICH/GCP guidelines and applicable laws and regulations
  • Collaborates with the Clinical Trial Administrators (CTAs)/Clinical Research Associates (CRAs)in terms of local authorities approval activities
  • Collaborates, in the overall management of the project, with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory…)
  • Collaborates with the CTAs in archiving activities
  • Deliver project specific trainings in function of their expertise
  • Organizes and participates in Monitor’s and Investigator’s Meetings
  • Takes part in the periodic project update meetings
  • Performs, if necessary, co-monitoring visits for the assigned clinical projects
  • Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable
  • May acts as Feasibility Associate (FEA) after appropriate and documented training
  • Maintains relations with the Sponsors, also providing projects updates, under the supervision of the PM/SPM
  • Prepares the SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU) in function of their expertise
  • Collaborates in complying and enforcing Company procedures

Job requirements:

  • University Degree in scientific, medical or paramedical disciplines
  • Up to three (3) years of assistant project management experience in the CRO/Pharmaceutical industry
  • Excellent knowledge of clinical trial operations, ICH/GCP Guidelines and other applicable regulatory requirements
  • Fluent English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel
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