Job Information
J&J Family of Companies Clinical Research Specialist II in Annapolis, Maryland
Clinical Research Specialist II - 2406194629W
Description
Laminar, part of the Johnson & Johnson family of Medical Device companies, is current recruiting for a Clinical Research Specialist II . This candidate for this role MUST be located within the Eastern half of the United States.
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/.
This Clinical Research Specialist II will be responsible for supporting one or more clinical trials within the Clinical Affairs Department while fostering, productive relationships with colleagues across the organization.
Duties and Responsibilities:
Serves as a Clinical Research Specialist within the Clinical Affairs Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones.
Provides on-site (cath lab or electrophysiology lab) procedural protocol compliance and data collection support to the clinical trial sites.
Serves as a first-line resource to clinical sites for overall site management. Possesses in-depth knowledge of the clinical protocol in order to answer clinical protocol inquiries or study process questions.
Facilitates timely and thorough screening of potential clinical study subjects. Reviews subject data during screening to ensure that subjects meet all study eligibility criteria.
Reconciles site invoices and payments.
Coordinates and completes ordering, tracking, and accountability of investigational devices and trial materials.
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Assists in clinical data review to prepare data for statistical analyses and publications.
Attends safety review meetings, requests, and processes source documents from clinical sites as requested.
Assists in tracking assigned project budgets.
Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Supports trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
May Participate in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the good clinical practices, applicable legislation and Company Standard Operating Procedures.
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
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, handles work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.
Qualifications
Job Qualifications:
Required:
Minimum of a Bachelor’s degree required
Minimum of 3 years of Clinical Research experience in a Sponsor-side Medical Device or Hospital environment required.
Presentation and technical writing skills.
Ability to analyze complex medical and scientific information, identify potential issues or risks, and develop practical solutions.
Written and verbal communication skills to effectively communicate with cross-functional teams, investigators, and other stakeholders.
Commitment to maintaining ethical standards in clinical research, including patient privacy, informed consent, and protection of human subjects.
Willingness to stay updated with the latest advancements, regulations, and industry best practices in clinical research and medical device technologies.
Preferred :
A Major in Biological sciences or a health related field preferred .
Relevant industry certifications strongly preferred (i.e., CCRA, CCRC, CCRP).
Clinical/medical background in interventional cardiology OR Medical device experience
Other:
Up to 75% travel to research sites (during the start-up phase of the program), conferences and/or other Laminar affiliated activities.
There is the potential for exposure to blood borne pathogens and other potentially infectious materials.
The base pay range for this position is $88,000 to $141,450 based on experience .
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 .
This job posting is anticipated to close on 6/28/24.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.
Primary Location NA-United States
Other Locations NA-US-California-Santa Rosa
Organization Biosense Webster Inc. (6010)
Relocation Eligible: No
Travel Yes, 75 % of the Time
Job Function Clinical Trial Support
Req ID: 2406194629W