Clinical Research Associate

Job Title：CRA

Location：US

Job Purpose

Perform tasks at a country level associated with Site Start Up activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Major Accountabilities

1、Under general supervision, serve as Study Site Start-Up activities coordinator in assigned studies for investigative sites, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

2、Perform site selection, start up and activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

3、Prepare site regulatory documents, reviewing for completeness and accuracy.

Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

4、Review and provide feedback to management on site performance metrics.

Inform team members of completion of regulatory and contractual documents for individual sites.

5、Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

6、Work with responsible Project Manager closely with the budget and contract negotiation and sign-off in timely manner.

7、Provide local expertise to project team during initial and on-going project timeline planning.

8、Perform quality control of documents provided by sites.

9、Maintenance of the eTMF until handover to site management team.

Requirements:

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Requires at least 1 year of work in clinical operations area.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers.
• Fluent English (oral and written)