26 days old

Clinical Studies Specialist II

Kelly Services
North Chicago, IL 60064
**Kelly Services** has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as **Clinical Studies Specialist II (4 positions)** at a prestigious Fortune 500 company in **North Chicago, IL**

**Length:1 year**


**Primary Responsibilities of the** Clinical Studies Specialist II **includes:**

Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. Trial Master File Owner responsible for managing and ensuring inspection readiness of clinical documentation / master files. Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF/artifacts to ensure completeness, document quality and timeliness of upload of artifacts to the TMF. Representative on study team(s) with ownership of the study Trial Master File (TMF). Develops and maintains study-specific TMF structure documentation. Provides TMF support for audits/inspections.

Ideal Candidate Profile:

- Adept with technology

- Highly organized

- Strong communicators

- Effective at motivating others

- 1-3 Years Experience Level.

Shift: Monday Friday. Hours can start as early as 6:30 AM. 8 hours on top of a lunch. Lunch can be 30 minutes 1 hour. Candidate can choose their start time as long as its consistent on a day-to-day basis.

a. Preferred Skill 1: Tech savvy regarding clinical trial management systems

b. Preferred Skill 2: Strong written and oral communication skills

c. Preferred Skill 3: Quality Assessment / Quality Systems

d. Preferred Skill 4: Highly organized

e. Preferred Skill 5: Experience working in documentation systems

1. Prior research site experience as a Research Coordinator or Regulatory Coordinator

2. Prior CRO experience as an in-house monitor

3. Quality and Compliance in GCP

4. Trial Master File experience

5. Audit/ Inspection preparation (GCP)

6. Prior experience as CRA

On-site role, with the possibility of working remote 2 days a week (after 3 6 months of demonstrating an ability to work independently)

Top Skills:

+ TMF, Clinical, Quality Assurance

+ Documentation

+ Inspection prep

**Additional Information:**

+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.

**Kelly Temporary Employee Perks:**

+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts

**Apply Now!**

**This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.**

**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-06-12 Expires: 2020-07-13

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Clinical Studies Specialist II

Kelly Services
North Chicago, IL 60064

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