Responsibilities:

 

Acts as primary site contact and site manager of a clinical research study, taking overall responsibility of allocated sites.

• Develops strong site relationships and ensures continuity of site relationships.

• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Initiation.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased.

o Subjects’ right, safety and well-being are protected.

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with related stakeholder.
• Manages and maintains information and documentation as appropriate and per timelines.
• Supports and/or leads audit/inspection activities as needed.

 

 

Qualification :

• B.A./B.S. with strong emphasis in science and/or biology
• Min. 1 years of clinical research related experience (e.g. CRC/CRA/CTA etc)

 

Additional information :

Ÿ   직책 및 직급: 직책 및 한글 직급 협의 후 결정 가능

Ÿ   급여 사항: 협의 후 결정

Ÿ   고용 형태: 정규직/경력직

 

Recruitment Process:

Ÿ   전형방법: 1차 서류전형/2차 & 3차 면접전형

Ÿ   제출 서류: 한글 이력서/자기소개서, 영문 이력서/자기소개서

Ÿ   접수 방법 및 문의 사항: 온라인 지원, HR@medirama.co,kr  

 

Others

Ÿ   면접은 서류전형 합격자에 개별 통지합니다.

Ÿ   제출하신 서류는 일체 반환하지 않습니다

Ÿ   입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

Ÿ   기타 문의 사항은 반드시 E-mail로 문의바랍니다.