Study Start Up Specialist

Kelly Science and Clinical FSP is currently seeking a Study Start Up Specialist for a long-term engagement in the US with one of our Global Medical Device clients in Irvine, California. This is a hybrid position on site Tuesday/Thursday and every other Friday. 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.

DESCRIPTION

• 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.

EXPERIENCE AND EDUCATION

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, MS and PhD with at least 1 year of relevant experience preferred.
• 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.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;
• Presentation and technical writing skills;
• Written and oral English communication skills.

Leadership Competencies:

Leadership required in alignment with J&J Leadership Imperatives:

• Connect - Develop collaborative relationships with key internal and external stakeholders.
• Shape - Actively participate in departmental process improvement activities.
• Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

TRAVEL REQUIREMENTS

• Ability to travel approximately 20% depending on the phase of the program.

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.
• May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.