Location: Lincoln, NE Area
Duration: 12 Months + (20 hrs/week to start, ramp up to 40 hrs/week)
Start Date: ASAP
Job Description: Our client is looking for a Clinical Research Associates to support three phase I units for their first in human study consisting of 10-100 subject. This person has to have extensive phase I experience including monitoring and testing safety. It would be great if this CRA has PK/PD experience to help analysis the drug-induced behavioral or physiological effects in the body. They will also Interact with the Clinical Project Manager, Global Project Manager, Clinical Study Manager, Study Coordinator and other Study Team members to ensure timely resolution of project/study issues; Attend regular Study Team meetings, as applicable; Maintain a working knowledge of all required IT systems and Perform other functions as assigned by Clinical Project Management.
Skills:
Clinical Research Associate
Phase I
First in Human
Additional Responsibilities
Perform on-site and in-house tasks according to contractual agreements with Sponsor/Client
Adhere to and maintain thorough understanding of all applicable procedures and policies (standard and study specific)
Perform Sponsor/Client specific training on controlled documents, policies, and study specific procedures as required and on time
Maintain exceptional understanding of protocols, CRFs, and other relevant study documents for all assigned projects/studies
Interact with supervisor and Study Team to develop a thorough and unambiguous understanding of all tasks required as well as project/study timelines and priorities
Contribute to continuous improvement efforts
Assist in establishing supportive monitoring tools (e.g. guides and checklists)
Report worktime and expenses, as well as site status to facilitate billing to Sponsor/Client
Follow administrative and reporting/documentation requirements of the client and clients, as necessary
Participate in audits, compliance visits, and performance reviews by Quality Assurance (QA) and Line of Service (LOS) associate
Education: BS
CRA (On-Site) – Lincoln NE (232800) Lincoln, NE
