Lead Clinical Research Associate

Were searching for a knowledgeable team-oriented and proactive leader to supervise the clinical aspects of full-service global projects in Korea. As a Lead CRA at PSI you will work on the frontline of communication with project stakeholders ensuring the successful conduct of clinical trials in a variety of therapeutic indications.  You will maintain the highest quality standards in the industry while performing and supervising study start-up clinical monitoring and site management activities on the country/regional level. 

Location: Hybrid in Seoul

Responsibilities: 

• Coordinates investigator/ site feasibility and identification process as well as study startup.
• Monitors project timelines and patient enrollment implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor Site Management Associate Regional Project Lead and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits may participate in site audits and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares conducts and reports site selection initiation routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined communicated recorded and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling use accountability reconciliation and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications :

• Relevant educational background such as MD MPharm RN or College/University degree in Life Sciences or an equivalent combination of education training and experience.
• Minimum of 5 years site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Must have prior experience monitoring or managing sites and CRAs in Korea with knowledge of Korean regulatory guidelines and practices. 
• Experience with all types of monitoring visits in Phases I-III. 
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy Gene Therapy Radiation Therapy or Radiopharmaceuticals or Nuclear Medicine is preferred. 
• Strong experience in GI (Chrons Ulcerative Colitis IBS) preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan multitask and work in a dynamic team environment.
• Excellent Communication collaboration and problem-solving skills

Additional Information :

Take the next step in your career and join a company that genuinely focuses on its people.

About Us

PSI is a passionate organically grown and award-winning full-service CRO who dares to be different. As a dynamic and global company we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.  

How are we different

PSI is privately owned by the very people who founded the company 30 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced innovative and results-oriented working environment with lean communication lines. We pride ourselves on being approachable receptive to new ideas and open to feedback.

Growth Opportunities

PSI is proud to invest in our people from entry-level team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.

Remote Work :

No

Employment Type :

Full-time