Clinical Study Coordinator

Kelly Science and Clinical FSP is currently seeking a Contract Clinical Study Coordinator in Irvine, California for a 6-12 month contract assignment with one of our Global Medical Device 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.

Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.

This is a hybrid opportunity Tuesday/Thursday and every other Friday on site

ummary of the Job:

The position is responsible for assigned Clinical Research tasks to support management of investigator-initiated and collaborative studies - Perform a variety of clinical research operations duties of a routine and technical nature in support of external research clinical trials. Other activities, special projects and assignments may be given as required.

RESPONSIBILITIES:

Assist external research director and manager with clinical research tasks.
Specific responsibilities include:

• Assists the Clinical Director in daily management of external research activities - investigator-initiated studies (IIS) and collaborative studies including the following responsibilities:
• As directed, provides support to the project team which may include tracking study data, following-up with clinical sites on essential documents / information; assist in drafting of agenda/meeting minutes and scheduling of meetings.

• Performs data entry in systems for study management, payment set up and processing
• Working collaboratively with legal/compliance and study institution/principal investigator on contract request, development, negotiation and execution
• Working with internal stakeholders (scientific affairs – global and regional) in daily management of external research in other countries outside of United States
• Follows SOPs and using sound judgment to assure IIS programs are in compliance with legal, regulatory, and company process requirements
• Data entry for payment set up in internal systems, co-ordinates with external research partners to problem solve problems
• Documents & files as instructed – study updates - milestones, invoices and payments
• Assists with management of IIS submission portal and maintenance of IIS database
• Managing device orders, shipments, and returns with appropriate documentation
• Assist with file reviews and Audit preparation
• Is responsible for ensuring appropriate level of communication with managers, project leaders, and team members.
• Performs other duties assigned as needed

REQUIREMENTS:

• Minimum of B.S.
• 0-2 years experience in the pharmaceutical/biotech/medical device/CRO industry;
• Experience with clinical study management highly preferred
• Knowledge of good clinical practice and fundamentals of research highly preferred
• Knowledge of medical device/pharmaceutical industry processes preferred
• Excellent oral and written communication skills
• Ability to work in a collaborative and multi-disciplinary environment
• Must be detail oriented, highly organized, and able to work independently
• Ability to multi-task in a fast-paced environment
• Competency in tools of Microsoft office – excel, powerpoint, teams
• Project management experience preferred

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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.