job summary: Clinical Trial Associate
location: Madison, New Jersey
job type: Contract
salary: $33.62 - 39.56 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- 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 Scientist to perform clinical data review.
- Assist with ongoing data review and discuss comments with the clinical study team as needed.
- Assist with the preparation and distribution of meeting agendas and minutes. Actively participate in team meetings.
- Provide input and support in the development and distribution of monthly site newsletters.
- 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 CS 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 Scientist activities as needed.
qualifications: Education & Qualifications
- Associate degree or higher preferred
- 1-2 year relevant experience in pharmaceutical industry or CRO
- Experience supporting clinical trials preferred
- 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
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: FDA, GCP (Good Clinical Practice), Study Planning, EDC (Electronic Data Capture), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.