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Job Details

Project Coordinator/CTC - Cambridge, MA, USA!

Company: ClinTec International Ltd
Location: Cambridge, MA
Reference: US-PROCOORD-110816-D
Closing Date: 13 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive

Job Summary:

Project Coordinator/CTC - Cambridge, MA, USA


Project Coordinator - Cambridge, MA - Permanent or  Freelance Contract 

ClinTec International is actively recruiting for clinical professionals to join our expanding global company in the US.  By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. In the past 12 months, we have expanded into 17 new countries with offices opening across the globe. Apply now and become part of our international team.

Job Description

The Clinical Project Coordinator is responsible for assisting the study team in running the day to day operational activities of clinical studies. The individual will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies.. The company is focused on indications related to anemia, oncology, and vascular development. Each indication will be developed in clinical studies performed on a global scale in coordination with international Clinical Research Organizations. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA)..

Responsibilities of the Clinical Project Coordinator:

  • Protocol review to ensure seamless integration between clinical objectives and study performance.
  • Works directly with internal clinical lead and internal and external medical experts to optimize and implement clinical studies.
  • Participate in CRO review, selection, and negotiation for each study.
  • Leads interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes.
  • Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
  • Joint responsibility with clinical lead for monitoring the implementation and progress of a clinical study.
  • Develops and maintains relationships with external vendors.
  • Collaborates with consultants and contractors to Research and Development.
  • Supports the development and implementation of standard operating procedures and common work practices within the team.
  • Clinical study team member: works closely with the Study Manager and Clinical Project Manager and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
  • Responsible for reconciliation of monthly invoices/PO management. Also responsible for investigator and vendor payments for in-house studies.
  • Works closely with Study Manager and legal to review and approve confidentiality agreement, clinical trial agreements and site specific study budgets
  • Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
  • Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
  • Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files along with internal working file.
  • Coordinates TMF transfer with CROs.
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.

Essential Criteria:

  • Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas. 1- 2 years of experience in clinical research operations preferred.
  • Experience in running one or more clinical studies in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
  • Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
  • Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
  • Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
  • Demonstrated ability to work independently with exceptional organization and attention to detail.
  • Excellent oral and written communication and presentation skills.
  • Willing to be office based in Cambridge, Massachusetts, United States

Company Information:

ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assist in their key product development efforts for over a decade. At ClinTec International, we pride ourselves provides high quality, flexible and professional services and solutions to our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.  

Apply for this job: Project Coordinator/CTC - Cambridge, MA, USA!

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
G3 8HB
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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