Kelly Services Clinical Scientist/Testing CRA in Raritan, New Jersey

Kelly Services’ Project Services Group is seeking a Clinical Scientist/Testing CRA for our customer in Raritan, NJ . This assignment is budgeted through October 18, 2019 and comes with enhanced benefits *. Under supervision of the Project Lead, the Clinical Scientist/Testing CRA plans and executes clinical studies of varying complexity in support of FDA 510k, PMA and BLA submissions and international registrations.

RESPONSIBILITIES:

• Prepares/assists in preparation of clinical study protocols and related documents.

• Works within US and international regulatory guidelines and GCP.

• Designs clinical study forms and manages version control.

• Conducts investigator site and vendor qualifications for participation in sample collection and IVD testing protocols.

• Identifies and selects Principal Investigators and clinical study sites.

• Assists in preparation of clinical study agreements and clinical site budgets.

• Monitors site costs and coordinates site payments.

• Develops site management and monitoring plans and participates in clinical study implementation.

• Prepares training documents, regulatory documents, data collection tools and study materials.

• Assists Data Management in the creation, updating and validation of clinical study databases based on project specific guidelines.

• Assist Data Management in the review, cleaning and auditing of clinical data following SOPS and regulatory agency guidelines.

• Trains Principal Investigators, study sites, CROs and vendors to assure GCP compliance and understanding.

• Participates in clinical study execution and study materials management.

• Reviews and monitors diagnostic testing data as received. Identifies, tracks and resolves data issues.

• Conducts periodic onsite monitoring of clinical sites to ensure protocol adherence, data integrity and regulatory compliance.

• Prepares/assists in preparation and maintenance of the trial master file.

• Assist in the review of data summaries.

• Assists in the preparation of clinical summaries and reports.

Qualifications

• Bachelor or higher degree required in a Biological science medical technology, clinical laboratory science, microbiology, infectious diseases, immunology, biochemistry, or closely related science

• Three or more years of clinical laboratory or R&D experience preferred.

• Previous experience in clinical research or equivalent experience in project management preferred.

• Must be willing to periodically work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments, utilizing appropriate PPE.

• Must be able to work both independently and within a cross-functional team environment.

• Must be skilled in common computer programs, e.g., word processing, graphics, spreadsheets.

• Travel up to 30% on an annual basis.

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

*This position comes with enhanced benefits which include:

• 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

• Paid holidays

• Paid sick days and vacation days*

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Online application system

• Never an applicant fee

*benefits to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

Why Kelly ® ?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm