Clinical Research Associate (Sr. or Specialist)

製薬企業にて臨床開発を実施

仕事内容

1. Function as project lead for complex clinical endpoint trials, bioequivalence (BE) studies and patient PK studies.
Serve as liaison between the our project team, Clinical Research Organizations (CROs), and clinical investigators
regarding study activities to include the scope of the clinical study; contract and budgetary information, project timelines; and requests for documentation.

2. Manage assigned studies to include CRO/site management and monitoring functions to include co-monitoring as
needed. Assist in the preparation project plans and provide project reports to management as needed.

3. Function as site manager for multiple Phase I focused CROs with responsibility to oversee assigned projects assigned
to that CRO. Ensure the CRO is compliant with assigned study protocols, overall clinical objectives, GCP, SOPs and
applicable federal, state and local requirements. Maintain all required regulatory study documents, monitoring records
and correspondence confidentially and in accordance with our document control procedures for assigned studies.

4. Review clinical and drug product documents for accuracy, completeness and timeliness internally and at the research
sites. This includes review of Regulatory Documents, Drug Release/Accountability paperwork, Source Document
templates, Case Report Form (CRF) templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol
Deviations, completed source documents, completed CRFs and Clinical Reports.

5. Conduct clinical monitoring of studies remotely and on-site as required according to our Standard Operating
Procedures (SOPs) and Clinical Monitoring Plan (CMP). This includes visit preparation, monitoring process, completion
of the monitoring report, visit follow-up activities and travel to and from the clinical locations.

6. Interact with clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any
substantial findings to his/her supervisor and clinical investigator during or immediately following a monitoring visit.
Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits,
as required.

7. Assist Clinical Project Manager in budgeting, finance tracking, Contracting, Purchase Requisitions, invoice tracking
and processing, document management and reporting.

応募条件

【必須事項】

Must possess knowledge of project management skills and monitoring of clinical studies. Knowledge of and
understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical
trials is required. Knowledge of medical terminology is desired.
(4-6 years of experience in the field)

【歓迎経験】

Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines.
Should be proficient in PC applications (Excel, Microsoft Word, Outlook, PowerPoint etc.).
Should have the ability to read and interpret documents.
Ability to write routine reports and correspondence.
(6-8 years ofexperience in the field.)

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスあり　コアタイムなし

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

土・日（完全週休2日制）、祝日 年末年始（7日）、夏期休暇（3日） 年次有給休暇（初年度4～11日、次年度11日、最高20日） 病気休暇（初年度1～5日、次年度以降6日）

年収・給与

年収　　600万円～800万円　経験により応相談

諸手当

通勤交通費全額支給

昇給

給与改定　年1回

賞与

業績賞与（※当社規定により決定）3月に支給

採用人数

1名　

待遇・福利厚生

【待遇】

退職金制度（確定給付＋確定拠出） 育児・介護休職制度 福利厚生「ベネフィット・ステーション」加入

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）最終面接