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).
• 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
• Associate degree or higher preferred
• 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
• 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:
• Clinical Document and Information Center (CDIC)
• Contracts Management
• Site Start Up
• Study team members
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