SR CRA RESOURCE ASSOCIATE

Sr.
CRA Resource Associate The Johnson & Johnson family of companies is currently recruiting for a Sr.
CRA Resource Associate.
The preferred location for this role is within a commutable distance of Somerville NJ or close to a Johnson & Johnson office.
Remote will also be considered.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
Summary.
On behalf of J&J MedTech, the Sr.
CRA Resource Associate is responsible for supporting the CRA Resource Manager by coordinating and tracking of monitoring and site management work performed by the monitoring resources.
Key Duties.
§ Support CRA Resource Leader in resource planning and allocation of functionally sourced staff and contractors § Tracks CRA workload and deliverables § Supports efforts to ensure efficient use of functional resources to provide efficient and high-quality deliverables § Provide guidance and advice to Clinical Research Associates on company procedures and regulatory authority requirements § Provide and/or coordinate training of Clinical Research Associates ensuring updates on specific requirements § May perform accompanied site visits to assess and ensure quality and efficiency of Clinical Research Associates § Support CRA Resource Leader US in the maintenance of quality standards, especially in monitoring and site management activities, using functional sourced staff § May participate in project management meetings and provide an overview of monitoring resources quality and workload on a regular basis § Provide internal communication of important clinical data and events.
§ Participate in departmental initiatives aimed at improving process and efficiency, for the improvement of local process § Provide technical support in preparation for incoming audits § Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance § May be involved in other tasks to support Clinical R&D Operations and Franchise Clinical R&D, as needed Qualifications Qualifications.
Required Education & Skills/Experience.
· A minimum of a Bachelor/University degree required.
· 4-6 years of relevant experience (or equivalent) required; · Requires understanding and application of US regulations and standards applied in clinical areas and medical devices/combination products · Requires at least 2 years of monitoring experience · Solid knowledge of monitoring and site management processes · Knowledge of current clinical regulations, standards, and good clinical practices · Written and Verbal Communications · Good presentation skills and effectively influencing of others Preferred Education & Skills/Experience.
· Masters with 3 years or PhD/MD/PharmD with 1 years of relevant experience preferred.
· Relevant industry certifications preferred (i.
., CCRA, RAC, CDE) · Medical device and pharma a plus · CRO monitoring experience a plus Other.
· This position may require up to 20% domestic travel.
The anticipated base pay range for this position is $ to $.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, [long-term incentive – include LTI only if applicable] disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
Additional information can be found through the link below.
https://www.
areers.
nj.
om/employee-benefits Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.