Clinical Study Administrator

Job Description

Job Description

Kelly Science and Clinical FSP is currently seeking a Clinical Study Administrator for a long-term engagement with one of our Global MedTech clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Job Description

Position Title: Clinical Study Administrator
Division: Clinical Operations
Reports To: Study Team Lead

This individual will provide support to the clinical study staff within Clinical Operations
Perform a variety of clinical research operations duties of a routine and technical nature in support of clinical trials.

Supports project managers within the assigned clinical studies.Key Job Activities:Under direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate procedures and guidelines, this position will

• As directed, provides support to the project teams which may include tracking study data, following-up with clinical sites on essential documents; assist in drafting and distributing study mailings, including study newsletters; assist in drafting of agenda/meeting minutes and scheduling of meetings.
• Assist in payments/tracking for patient reimbursements.
• Performs data entry in systems
• Run reports including training matrix reports, metrics for management reviews
• Support management of IRB/IEC renewal compliance.
• Coordinate process for the review of study data, such as MRIs, by third-party vendors.
• Assist in ordering, shipping, tracking of, study supplies including, but not limited to, investigational devices and site binders. Maintain master device accountability log as requested.
• Assist with scheduling and organizing investigators and expert panel meetings.
• Assist with file reviews and Audit preparation
• Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.
• Work with management group to help achieve department goals.
• Participate in process improvement activities within the department.

• May be involved in other tasks to support Clinical Operations and Operating Company as needed.

Other Administrative Tasks

• Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

• May be asked to provide additional support to Clinical Operations staff, as needed.

Job Qualifications
Education

• Minimum of a Bachelor’s Degree is required.

Experience

• Previous clinical research experience
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background

Knowledge

• Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).

Additional Requirements

• Demonstrated competencies in the following areas are required:
  • Tracking
  • Written and verbal communications
  • Attention to details
  • Organizational skills

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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