Job Description
Clinical Trial CoordinatorGalil Medical is currently seeking an experienced Clinical Trial Coordinator to join our team in Minneapolis, MN.
Job Description:
The primary purpose of the CTA is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). They also act as a pivotal point of contact & support for the clinical trial team. The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial.
Job Responsibilities:
- Managing study site, consulting, or vendor contract agreements (e.g. obtain signatures, distribute copies, filing, renewal schedule)
- Arranging & participating in the organization of Investigator Meetings & Study Team Meetings. Taking minutes & distributing.
- Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
- Preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
- Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)
- Managing and maintaining study documents & trial supplies
- Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
- Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
- Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
- Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis as requested.
- Setup of clinical finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
- Assist with collating and shipping CRFs & data queries to Data Management
- General study filing
- Coordinating archiving of study documentation
Job Requirements
Education and Experience:- High School diploma or equivalent required, BA degree preferred
- Previous experience in clinical research preferred
- Secretarial/Administration experience
- IT literacy, particularly in MS Word, Excel and PowerPoint
- Personal Skills (description of the personality characteristics required for this position)
- Quick to learn
- Excellent organizational skills
- Good attention to detail
- Work under pressure and to deadlines
- Pro- active, flexible and able to multi-task
- Self-motivated
- Work well in a team and independently
- Excellent time management
- Excellent communication (written and oral) and vendor-management skills
Compensation and Benefits:
- Compensation is commensurate with experience
- Benefits package available
To Apply:
Please submit your resume via the "Apply Now" button.
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Equal Opportunity Employer
Country: USA, State: Minnesota, City: Saint Paul, Company: Galil Medical.
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