Clinical Research Associate
募集要項
| JoB No. | 282 |
|---|---|
| 業種 | CRO/SMO/CSO |
| ポジション名 | Clinical Research Associate |
| 職種 | 臨床開発 |
| 業務内容 |
Clinical Development Operations • Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected. • Primary point of contact of trial sites with regards to the conduct of the study/ project • Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work • Ensure that the sites are adequately trained on the protocol and other study specific requirements • Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan • Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF). • Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary. • Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution. • Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF) • Track site budget and payments • May be involved in preparation of status reports for clients • Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary • Act as mentor/coach to more junior staff as necessary • Travel as necessary according to project needs • Perform other duties as assigned by line manager Regulatory |
| 勤務地 | 東京都 |
| 応募資格 |
Qualifications: • Bachelor’s degree in life science, chemistry, or health is preferred. • ICH-GCP training is required • Relevant experience on conduct of clinical trials – Strong preference on candidates with more than 3 years of experience – However, Ascent is interested in looking at all quality candidates • Excellent communication, both written and verbal, and interpersonal skills • Fluency in English is required • Proficiency in MS Office programs |
| 雇用形態 | 正社員 |
| 年収目安 |
経験。スキルによる ＊想定年収：450万～650万 |
| 備考 | －－－ |
| 担当コンサルタント | 小川 善之 |
企業情報
| 企業名 | — |
|---|---|
| 事業内容・会社の特徴 | — |
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