Remote Lead CRA - Full-time / Part-time

Description:

The Lead CRA will manage the development, coordination, and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects. This role will also guide trial-specific processes and systems and provide daily supervision of the clinical operations team.

Responsibilities:

• Responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations and ICH guidelines.
• Provide leadership for functional group leaders for the execution of all monitoring services according to the project specific scope of work. Position will also budget with minimal guidance.
• Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.
• Position will serve as key site management trial team member to internal and external partners and to the project core team (project leader, principal investigator, and other functional group key representatives.)
• Position will collaborate with clinical operations administration to identify and oversee trial related training and performance concerns of monitoring team members according to their individual needs; maintain awareness of level of performance and training needs; provide ongoing input to clinical trials leader for development of individual training plan.
• Position reports to a Project leader and a Line manager for daily activities. Position typically leads the monitoring team composed of clinical research associates I, II, and III for all Clinical Trials activities through startup, enrollments, closeout and archiving.

Requirements:

• Bachelor’s degree or Registered Nurse/Nurse Practitioner or Physician’s Assistant or Pharmacist
• 4-5 years related clinical research experience including 3 years directly related CRA experience or clinical trial management experience
• Ability to travel 25%, some for consecutive nights

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.