1. Oncology CRA

Qualified CRAs worldwide and across the United States

Job Description

• Performs and coordinates all aspects of the clinical monitoring process in accordance with FDA Regulation, ICH-GCP, SOPs and study protocols.
• Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation.
• Responsible for multiple projects and must work both independently and in a team environment.
• Active participation in study development and initiation process including reviewing protocols, designing and /or reviewing CRFs, preparing Informed Consent Forms as well as developing a monitoring strategy.

Qualifications

• BS/BA with experience in oncology clinical research, with two years of on-site clinical monitoring experience.
• This position requires excellent verbal and written communication skills.
• An excellent interpersonal skill with strong organizational skills with attention to detail is needed.
• Computer literate with proficiency in MS office.
• Must be willing to travel depending on project needs.


2. Project Manager or Lead Senior CRA

Now hiring for positions in Nebraska, Nevada, Arizona, New Mexico and Utah

Job Description
• The lead manager is responsible for the overall coordination and management of the clinical research project.
• Responsible for management of multiple protocols national and international bases.
• Tracking of clinical data and preparation of study specific documents according to FDA regulations and ICH-Guidelines.
• Oversees project team to ensure the progress of the project timely and within the budget.
• The manager will coordinate client and team members and will act as liaison with clinical operations; clinical Biostatistics and regulatory Compliance, and other departments.

Qualifications:

• Doctor or RN, BS or MS preferred.
• Experience in Oncology clinical trials is a plus.
• Ability to perform all tasks required of Sr. CRA, experience in clinical trials monitoring; expert knowledge of FDA ,ICH guidelines and GCPs;
• Strong computer skills
• Leadership and organizational skills
• Excellent interpersonal skills, oral and written communication skills, and problem solving/decision making strategies