Clinical Trial Associate/ Documentation Management Specialist
IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical service provider in the field of clinical research. To support our growth, we are actively looking for a:
Clinical trial associate / Documentation management specialist
You will be joining an international and multi-cultural company that includes over 20 different nationalities with English as our working language. Our employees are our strongest asset. Our customers value our flexibility, responsiveness and proactive approach.
By joining a group of 15 highly skilled specialists in the Project & Document Management team, the successful candidate will strengthen the experienced group in Raleigh, NC – US (office based position).
As Clinical Trial Associate (CTA) and Documentation Management Specialist you will work together with the Project Managers and Project Coordinators to ensure that key project information are up to date and you will act as a compliance expert in Document Lifecycle and Classification.
Your responsibilities will be to:
As Clinical Trial Associate:
- Work together with the Project Managers and Project Coordinators to ensure that key project information related to project milestones, team members, training records and electronic Trial Master File are up to date.
- Initiate and coordinate archiving of studies.
- Support Project Managers in preparing study trackers and following up on study meeting and planning.
- Write meeting minutes for study meetings.
- Provide support to the Data Monitoring Committee (DMC) Project Coordinators in the organization, contracting and follow-up of DMC meetings.
As Documentation Management Specialist:
- Act as compliance expert in Document Lifecycle and Classification and act as back-up System Administrator for the Document Management Systems Specialist.
- Develop and maintain document lifecycles and content classification in order to facilitate document review and approval according to characteristics such as security level, function and metadata.
- Be an eTMF Core team active member.
- Consult with end users regarding document management requirements.
- Follow-up on agreed action plan.
The successful candidate must have an experience in taking meeting minutes and writing concise summaries of meeting. You also have experience in clinical trials research and with Good Clinical Practice. In addition, the position requires:
- An experience with electronic Trial Master files and archiving is an asset.
- Familiar with Trial Master File Structure and Essential Documents.
- Excellent knowledge of English, both oral and written.
- Good working knowledge of Microsoft Word and Excel.
- Ability to prioritize and to manage several tasks at the same time.
- Proactive and reactive and ability to work independently.
- Methodical, logical, detail and quality oriented.
- Organized with excellent administrative skills.
- Ability to solve problems and to motivate others.
A unique opportunity to work in a friendly, team-oriented and stimulating environment. We regularly enjoy company-wide events such as BBQs, family-day outings, sports, and charity fundraisers, giving the chance to share time together. With a low employee turnover rate, we offer job stability and growth opportunities through on-the-job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry. We offer a competitive salary and benefits package including health, dental and vision insurance plans, short and long term disability insurance, life insurance as well as flexibility for a better work-life balance (working hours, home-working opportunities, paid time off).
Interested in this challenging position?
Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e-mail at email@example.com (to the attention of Ms. Marie-Pierre Debroas).