MEDPACE에서는 사세 확장에 따라 아래와 같이 채용을 합니다.
MEDPACE 는 미국에 설립된 Global CRO로 본사는 미국 Cincinnati에 있으며 North/south America, Europe, Asia, The Middle East, Australia, Africa 대부분의 국가에 지사를 두고 있습니다.
MEDPACE 한국 지사는 2012년 한국에 설립 된 이후 현재까지 다양한 영역에서 Global 과제들을 전문적으로 수행하고 있습니다. 입사 시 직원들에게 충분한 training 기간을 통해 업무와 회사생활에 적응 할 수 있도록 지원하고 있으며, work& life balance를 통해 직원과 회사가 상생하는 것을 지향하고 있습니다.
관심 있는 여러분의 많은 지원을 바랍니다.
1. Clinical Trial Assistant
- Provide day-to-day departmental/project support with general contract administrative duties;
- Assist with preparation of final contract documentation, liaising with study teams and study centers; and
- Perform other administrative tasks as needed to support successful contract negotiation/execution.
- Bachelor’s degree;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office programs; and
- Attention to detail and excellent oral and written communication skills.
2. Clinical Research Associate
- Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s);
- Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs);
- Serve as the primary resource to the clinical investigator and site staff;
- Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams;
- Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ® Monitoring Portal; and
- Must have and maintain a valid driver’s license and the ability to drive to monitoring sites. This specifically applies in the US, Canada, any countries where cars/car allowance are provided by Medpace, and other countries dependent on monitoring travel and patterns as designated by Medpace.
- Bachelor's degree +3 years of clinical monitoring experience.
- Comprehensive knowledge of practices and procedures relating to all clinical monitoring visit types, including practical application of this knowledge;
- Demonstrated ability to act as a Lead CRA (as applicable);
- Act as a resource for new CRAs and ability to facilitate training and serve as a mentor for new CRAs; and
- Implements new ideas/solutions, without prompting, within their authority.
3. Regulatory Submissions Coordinator
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- Bachelor's degree in the science field or equivalent combination of education and experience;
- At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Experience in preparing and submitting regulatory applications;
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office;
- Knowledge of ICH - GCP guidelines;
- Knowledge of regulatory guidelines
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries
- Proactive approach to role with ability and willingness to learn and be challenged;
4. Contract Specialist
- Serve as a liaison between Sponsor, investigative sites, and Medpace;
- Negotiate contracts and budgets directly with investigative sites; and
- Collaborate with internal project teams to ensure negotiations occur within timelines.
- Bachelor's degree;
- A minimum of 2 years’ experience with contract and budget negotiations (industry experience preferred); and
- Strong attention to detail and excellent communication skills.
5. Regulatory Submissions Manager
- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.
- More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Regional experience will be highly advantageous
- Strong oral and written communication skills.
* 근무지: 서울 중구 을지로5길 19 페럼타워 (2호선 을지로 입구역)
* 지원방법: Email(E.Kim1@Medpace.com) 로 영문이력서 (MS Word or PDF) 발송