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Clinical Trial Assistant

Company:
LanceSoft INC
Location:
Jersey City, New Jersey, United States
Posted:
December 05, 2016
Description:

ROLE SUMMARY:

Responsible for supporting the Clinical Trial Management/operational study team to manage the various aspects of the operational execution and delivery of quality studies, including in process quality control activities.

PRIMARY JOB RESPONSIBILITIES:

Primary responsibilities of this position include:

• Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies

• Organize and maintain project working files and track critical documents. Report discrepancies to the appropriate clinical team member in a timely manner.

• Reconcile and transmit all essential documentation to CDIC as per Forest policy.

• Track and assist with processing site/vendor payments. Follow up on any issues as required.

• Collect and track patient enrollment information and update study management reports as necessary.

• Participate in testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems.

• Generate reports in various applications to assist the Clinical Trial Managers to perform clinical data review.

• Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.

• Support the Regional Site Managers by providing study related information and supplies, as requested.

• Communicate with IRBs and outside vendors to provide information and/or resolution to specific requests/issues.

• Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).

Additional Responsibilities:

• Contribute to process improvement efforts including task forces and committees.

• Support clinical team with requests from management as needed.

• May deliver training related to day-to-day responsibilities for new CTA and CTM hires within department.

• May provide administrative support to manager/group as assigned.

• Manage calendars and appointments. Resolve scheduling conflicts as needed.

• Support document filing and organizing as needed.

• Schedule and coordinate new hire candidate interviews.

• Coordinate and process office supply orders.

• Function as a back up to general Clinical Trial Manager activities as needed.

CSR Development and Reporting:

• Responsible for providing operation support into the CSR

JOB QUALIFICATIONS:

Education:

• Associate degree or higher preferred

Experience:

• 1-2 year relevant experience in pharmaceutical industry or CRO

• Experience supporting clinical trials preferred

Knowledge, Skills, and Abilities

• Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus

• Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat

• Strong skills with Microsoft Excel required

• Experience using electronic data capture (EDC) systems is a plus

• Must possess excellent skill/ability in the following:

• Oral and Written Communication

• Organizing

• Judgment and Problem Solving

• People Relationships

• Initiative and Accountability

• Ability to manage multiple tasks

V. SCOPE OF POSITION:

Supervision Received: Supervised by Clinical Trial Manager, Clinical Operations; Mentored by, and receives direction for specific study activities from Clinical Trial Manager

Supervision Exercised: NA

VI. PRINCIPAL CONTACTS:

Internal:

• Clinical Document and Information Center (CDIC)

• Contracts Management

• Site Start Up

• Study team members

• Informatics

External:

• Sites

• Vendors

• IRB