Clinical Research Specialist - Study Start Up

SUMMARY:
This Clinical Research Specialist - Study Start Up, will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Responsibilities:

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• May serve as the primary contact for clinical trial sites (e.g. site management);
• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);
• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
• Interfaces and collaborates with Clinical Research Associates (CRAs);
• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;
• Assists in clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
• Assists in tracking assigned project budgets;
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

Education

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience

• BS with at least 2 years of relevant experience
• Previous experience in clinical research or equivalent is desired.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
• Clinical/medical background is a plus.
• Medical device experience is a plus.

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.