• INGLEWOOD
• /
• CA

Clinical Research Project Associate (Full-Time)

KCRN Research is an established Contract Research Organization serving both commercial as well as government markets.(Headquarter is located at Germantown, MD)

KCRN Research (CRO) 에서 Inglewood CA 오피스에서 함께 지낼 Full-time CRA를 찾고 있습니다.

관심 갖고 계신분은 Current Resume와 Cover Letter 를junykim@kcrnresearch.com 와 jieunkim@kcrnresearch.com 보내주시면 감사하겠습니다.

We are currently seeking highly motivated Clinical Research Associates (CRA) at the company's office in Inglewood, CA.

* This position will support a variety of trials, covering a wide range of therapeutic areas.

Primary Responsibilities

•Performs all clinical monitoring/site management activities for assigned projects in accordance with Company’s standard operating procedures.
•Develops and maintains collaborative working relationships with clinical investigative sites.
•Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
•Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
•Act as direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
•Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits by using SOP systems and completes reports to quality standards within company specified timelines.
•Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
•Function as a mentor and role model for other CRA team members
•Manage clinical monitoring activities, including:

-Arranging on-site visits
-Monitoring completeness and quality of Regulatory Documentation
-Performing site documentation verification
-Data collection and drug accountability in accordance with ICH GCP guideline
-Monitoring patient safety on-site and addressing any violations in a timely manner
-Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.

Requirements
•Degree in health- or biological science-related field preferred
•1 ~ 3 years of prior experience in the research or pharmaceutical industry
•Knowledge of ICH GCP, and HSP regulations
•Experiences in a variety of therapeutic areas a plus but not required
•Detail oriented, good oral and written communication skills required

Thank you for your time and attention.
감사합니다.