**Clinical Research Associate (Job Number: 161371)**
**Description**
We are seeking a **Clinical Research Associate II** responsible for the execution of clinical trials through clinical monitoring.
**Essential Duties and Responsibilities**
+ Conduct Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities in accordance with FDA Code of Federal Regulations, Good Clinical Practice, guidelines, departmental procedures and the Clinical Monitoring Plan (CMP)
+ Ensures records are complete and consistent with governing regulations
+ Able to use or uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
+ Assists sites with site-level IRB submissions, queries and documentation
+ Establishes and maintains regular communication with clinical sites
+ Conducts on-site interim site monitoring activities including document review, source data verification, informed consent forms, other site documentation and study material accountability
+ Prepare and complete monitoring visit reports and letters, and effectively document site communications Identify and address routine site issues including protocol deviations, subject recruitment and retention programs and communicate any observed study /data trends and proposed resolution
+ Resolves non-routine site issues in conjunction with the Study Lead
+ Assist with the development of clinical trial documents
+ Ensures distribution, collection, and tracking of regulatory documents to ensure site compliance and audit readiness
+ Assists in the validation and QC of clinical study database(s)
+ Provides input into the development of Clinical Monitoring Plan, informed consent forms, template source documents, study manual, regulatory binder and other study-related documents as needed
.
**Qualifications:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
+ Advanced knowledge of clinical trial practices and regulations.
+ Advanced knowledge of clinical monitoring and trial design.
+ Proficient use of clinical trial databases.
+ Proficient knowledge of technical computer systems.
+ Willing to travel up to 50%.
**Education & Experience:**
+ College Degree and minimum of 2-5 years of clinical monitoring experience.
**Agency and Third Party Recruiter Notice:**
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
**_Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor_**
**Primary Location:** _United States-California-San Diego_
**Organization:** _Research & Development_
**Schedule:** _Full-time_
**Shift:** _Day Job_
**Travel:**
**Job Posting:** _Sep 2, 2016, 5:25:42 PM_