Category: Scientific & Clinical
Clinical Research Associate
Location: Princeton, NJ
- At least 2 years experience in a pharmaceutical, bio tech,CRO or Healthcare setting
- Experience working with CRO's and outside vendors
- OK with 25% domestic travel
- Ability to work in a virtual, cross-functional team environment.
- Knowledgeable of clinicalresearch operations and FDA regulations/ICH/GCP guidelines
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
- Excellent verbal and written communication skills
- Team player; willingness and ability to fill functional gaps
- Selfmotivated and adaptable to a dynamic environment
- Willingness to travel (~25%)
- Comfortable multi-tasking in a fast-paced small company environment
- Acts as primary point of contact for investigative sites and cross functional teams and escalates to the study lead as necessary.
- Assists in the development of study-related documents such as study manuals,monitoring plans, informed consents, recruitment materials and other study related tools.
- Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and User Acceptance Testing (UAT).
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.
- Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates.
- May participate in co-monitoring and/or training visits, TMF and on-site audits as requested.
- Participates in the training of investigative sites and third-party vendors.
- Assists with providing oversight of CROs and vendors, including managing crossfunctionalteams.
- Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
- Assists with the organization and management of internal meetings, investigator meetings and other trial specific meetings as required.
- Performs other work-related duties as assigned