Clinical Trial Coordinator II - Johnson and Johnson

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.jnj.com/.

Johnson & Johnson MedTech, is recruiting for a Clinical Trial Coordinator II, located anywhere in East coast or Midwest in United States.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.

At Johnson & Johnson, we all belong.

Job Description:

The Clinical Trial Coordinator (CTC II) supports the planning and coordination in all aspects of clinical trial operations. This position requires a thorough understanding of clinical trials, including how to support a trial from site feasibility/qualification to site activation. A CTC II will work closely with the clinical project team to collect all essential regulatory documents for a clinical study (at both study and site level) in a timely fashion and store appropriately while ensuring compliance with ICH/GCP guidelines, federal regulations, and corporate policies and procedures . The position involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.

Primary Duties and Responsibilities:

• Support the management of trial-related systems such as the electronic Trial Master File (eTMF), including set up, maintenance and study close out.

• Assures collection of essential clinical trial documents (i.e., CVs, Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements) from investigational sites for efficient study start-up/site activation.

• Support site start-up activities including reviewing study specific ICF templates, managing and communicating the status of sites and study's start-up progress.

• Plan, coordinate, and arrange study communications on and off-site with both internal and external partners.

• Responsible for supporting the drafting of meeting agendas and detailed meeting minutes.

• Maintain quality of collected regulatory documents, which include a precise QC process and proper review in accordance with Good Documentation Practices (GDP) when documents are received.

• Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions and other trial-related information.

• Collaborate with multifunctional teams to resolve issues on collected essential documents as required per assigned studies.

• Maintain accuracy of clinical trial registration information.

• Provide assistance with communication and coordination for trial committee interactions, as needed.

• Provide support during audits and inspections, as applicable.

• Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager.

• Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.

• Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.

• Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.

• Ability to perform additional responsibilities as requested.• Bachelor's degree preferably in Life Sciences, Nursing, Business Administration or related medical/scientific field with 2 years of experience

• OR associates degree with minimum of 3 years relevant clinical research experience working at an Investigator Site, Sponsor or CRO .

• Knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements.

• Experience working with eTMFs and CTMS preferred.

• Must be computer savvy and highly proficient in Microsoft Office: Word, PowerPoint, and Excel (i.e., format documents, presentations, spreadsheet formulas).

• Able to work and thrive in a fast-paced team environment across cross-functional teams.

• Highly organized, excellent prioritization, self-motivated, and detail oriented.

• Demonstrate excellent communication, verbal and written, and interpersonal skills.

• Ability to travel ~5%.

This job posting is anticipated to close on 10/10/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base salary for this position is $88, 000 to $97,999.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.careers.jnj.com .

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.