I. 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.
II. PRIMARY JOB RESPONSIBILITIES:
Primary responsibilities of this position include:
• Supports the Clinical Trial Management/operational study teams in the execution and delivery of studies
• Support study feasibility activities and perform database/web searches for sites as needed. Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
• 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.
• Assist senior team members with in the planning, preparation, and on-site support of investigators meetings.
• 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.
• Manage and coordinate travel requirements for group, consultants, and partners.
• Prepare and oversee expense account reporting. May contribute to tracking budgets 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
III. JOB QUALIFICATIONS:
• 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
IV. PHYSICAL REQUIREMENTS:
The requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Refer to the Position Description - Office Position – with minimal travel ( up to 5%)
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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