Position Title: Clinical Research Associate (CRA)
Function: Clinical Development
Report To: (Associate) Director of Project Management
Entity: Laekna Therapeutics
Location: Beijing/Shanghai/Other Cities
The CRA has responsibility for the delivery of the studies at allocated sites and are active participants in the study team(s). The CRA works in close collaboration with other CRAs and the Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of sites in clinical studies according to Laekna Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials.
1.Obtain and maintain essential documentation in compliance with ICH-GCP, Laekna Procedural Documents and local regulations both in the office and at site.
2.Actively participate in local Study Delivery Team meetings.
3.Contribute to the selection of potential investigators.
4.Train, support and advise Investigators and site staff in study related matters.
5.Contribute to national Investigator’s meetings.
6.Initiate, monitor and close study sites in compliance with Laekna Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
7.Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
8.Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
9.Perform source data verification according to monitoring plan.
10.Ensure data query resolution.
11.Ensure accurate and timely reporting of Serious Adverse Events.
12.Prepare for activities associated with audits and regulatory inspections in liaison with project manager and QA.
13.Provide the required monitoring visit reports within required timelines.
14.Work with data management to ensure quality of the study data.
15.Ensure completeness of the Study Master File. Ensure that all study documents are ready for final archiving and sign-off completion of the Trial Master File.
16.Ensure timely customization and completion of the CSA for designated studies.
17.Track and manage agreed payments at study site level.
18.Participate in training and mentoring of new members of the Study Delivery Team ensuring compliance with ICH/GCP and Laekna Procedural documents.
19.Ensure compliance with Laekna’s Code of Conduct and company policies and procedures.
20.Contribute to process improvements, knowledge transfer and best practice sharing.
1.University degree in related discipline, preferably in life science, or equivalent qualification.
2.Fluent knowledge of spoken and written English.
3.Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
4.Good knowledge of relevant local regulations.
5.Good medical knowledge in relevant Laekna Therapeutic Areas.
6.Basic understanding of the drug development process.
7.Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
8.Ability to travel nationally as required.
Laekna Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Follow us on Linkedin