CLINICAL TRIAL ASSISTANT

Full Time, Temporary

 

 

Summary

Clinical trial support position responsible for project and administrative tasks for one or more clinical trials.  Responsible for supporting clinical trial team in executing clinical trial processes from start up through closeout.

 

Responsibilities and Essential Duties:

Responsible for project and administrative support for one or more clinical trials

 

Maintain, update and distribute study contact list to clinical trial team

 

Coordinate purchase order generation

 

Coordinate copying, printing, distribution, assembly, tracking and shipment of clinical trial documents such as protocols, study manuals, regulatory binders, pharmacy binders, central lab supplies and all required study documents

 

Initiate and track confidentiality agreements with investigators

 

Development and maintenance of project management tools, trackers and reports

 

Liase with clinical trial team to facilitate and track IRB submissions

 

Set up, organization and maintenance of project and central files

 

Coordinate licensure of clinical trial questionnaires and arrange for translations as needed

 

Arrange clinical team meetings, teleconferences and generate and distribute meeting minutes

 

Oversee supply of office resources necessary to develop study related materials

 

Qualifications

BS degree required.

 

Strong administrative background with healthcare experience preferred.

 

1-3 years clinical research experience required in a pharmaceutical, biotech or CRO setting preferred.

 

Previous experience in clinical research or in a drug development environment a plus.

 

Excellent interpersonal, organization skills

 

Ability to work in a fast paced, dynamic setting

 

Ability to manage multiple tasks in a collaborative environment

 

Excellent written and communication

 

Strong computer skills (Microsoft Word, Outlook, Excel, Powerpoint)

 

Working knowledge of GCP, ICH and FDA regulations

 

Ability to interface and communicate with medical team members

 

Detail oriented, strong problem solving skills

 

Positive, self motivated team player

 

Please send resume to Leslie Simpson

leslie.simpson@aerist.com