Clinical Research Associate II (FSP)-Shanghai

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Monitoring and Management of Investigator Sites

Conducts source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion

Identifies issues that may impact on the conduct of the study and ensure appropriate closure of all issues

Proactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met

Ensures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs) and procedures

Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements

Informs the Principal Investigator (PI) and site staff of all issues

Agrees and develops corrective and preventative actions with PI and site personnel to close all open issues

Responsible for all aspects of site management from collaboration on site selection to study closeout

Trains site staff on the protocol, protocol amendments and Client processes

Understands the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team

Interacts with health care professionals in a manner, which enhances Client’s credibility with the customer

Data Quality

Ensures that data monitored meets target quality standards

Ensures that data is entered into Client systems in a timely manner

Reporting

Reports on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred

Ensures all issues are correctly identified and catalogued

Proactively manages issues to appropriate closure

Maintains accurate site-level information on corporate clinical trials registry

Documentation

Obtains critical information to enable generation of Investigator Initiation Package (IIP) documentation

Assists Clinical Trial Assistant (CTA) in gathering IIP documentation where required to ensure timely site set up

Maintains the Site Master File (SMF) and SMF log

Ensures Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurate

QC relevant documents in ELARA and/or TMF in a timely manner

Generates site monitoring reports

Maintains all appropriate monitoring logs

Compliance with Parexel standards

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains a working knowledge of and complies with Parexel processes, ICH- GCPs and other applicable requirements

Skills:

Computer Literacy (word processing and spreadsheets, PowerPoint)

Proficient in Chinese, good command of written and spoken English is required

Good interpersonal skills, good at communication

A flexible attitude with respect to work assignments and new learning, quickly-learning

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

Willingness to work in a matrix environment and to value the importance of teamwork

Knowledge and Experience:

At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience, global study monitoring experience is preferred

Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research

Education:

Degree in Life Science, Nursing, Pharmacy, or other relevant education background

Bachelor’s degree or above, or equivalent