Sr Clinical Research Associate

Johnson & Johnson; Danvers (MA); Remote; USD 104,000 - 167,000; Full time

Job summary

An established industry player seeks a Sr. Clinical Research Associate to lead investigational site activities for clinical trials. This role is vital in ensuring compliance with guidelines and regulations while fostering collaboration across teams. You will be responsible for study start-up, monitoring, training, and documentation oversight, making a significant impact on healthcare innovation. With a commitment to diversity and inclusion, this forward-thinking company offers a dynamic work environment that encourages professional growth and development. If you are passionate about advancing healthcare solutions and thrive in a fast-paced setting, this opportunity is perfect for you.

Benefits

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Qualifications

• 5 years of field monitoring experience required.
• Clinical research certification preferred.
• Experience in medical device or regulated industry preferred.

Responsibilities

• Manage day-to-day investigational site activities on clinical trials.
• Ensure compliance with international guidelines and regulations.
• Conduct site monitoring visits and training for site personnel.

Skills

Excellent written and verbal communication

Presentation skills

Interpersonal skills

Analytical skills

Problem-solving skills

Critical thinking skills

Ability to travel

Education

Bachelor's Degree in related field

Tools

MS Office Suite

Electronic data capture

Job description

Job Description - Sr. Clinical Research Associate (2406222567W)

Description

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 Sr Clinical Research Associate, located anywhere in the United States.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

Reporting to the manager of clinical research associates, the person in this role is responsible for the management of day-to-day aspects of investigational site activities on assigned clinical trials.

The Clinical Research Associate should ensure compliance with international guidelines, local regulations, and corporate policies and procedures. Successful candidates will be forward-thinking, anticipate needs, and be able to work well in a fast-paced environment, either independently or as part of a collaborative team.

Key Responsibilities:

• Study start-up and conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing, and communicating the status of study progress and activities.
• Partner with cross-functional teams (e.g., clinical data management, medical teams) with query management, data reviews, and resolution.
• Provide coaching and training to junior employees.
• Lead in the investigation of all discrepancies in study documentation, applying clinical protocol knowledge and GCP, and develop processes to mitigate reoccurrence throughout study phases.
• Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations.
• Prepare materials for steering and investigator meetings.
• Conduct site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
• Conduct site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study.
• Assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and monitor clinical trial/study safety, keeping with protocols, GCP, PHI, and regulatory requirements.
• Manage monitoring progress of contract & CRO CRAs for respective sites.
• Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements.
• Provide oversight of and insight into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff.
• Contribute to the development of clinical protocols, informed consent forms, and case report forms.
• Validate investigational device accountability by tracking the history of investigational devices from Abiomed to the field sites and through final disposition.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external.
• Edit/amend informed consent documents.

Qualifications:

• Bachelor's Degree in related field with 5 years of previous field monitoring experience required.
• Excellent written and verbal communication, presentation, interpersonal, and analytical skills required.
• Demonstrated problem-solving and critical thinking skills.
• Proven expertise in MS Office Suite, including Word, Excel, Adobe.
• Experience working in a medical device or regulated industry preferred.
• Experience with electronic data capture preferred.
• Clinical research certification (ACRP or SoCRA, Clinical Coordinator/CRA certification) preferred.
• Ability to travel up to 65% required.

Location: Home Based (Remote, US)

This job posting is anticipated to close on 11/27/2024. The Company may, however, extend this time-period.

The anticipated base pay range for this position is 104000 to 166750.

For California Bay area: $119,000 - $191,000.

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.

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.