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Senior Clinical Research Associate
LEO Pharma Inc. Madison, NJ
Full Time | Wholesale 6 Months Ago
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LEO Pharma Inc. is Hiring a Senior Clinical Research Associate Near Madison, NJ

Thank you for your interest in the Senior Clinical Research Associate

Purpose/ObjectiveAn independent monitoring role, with developing expertise and a tactical focus. An emerging leader within Global Site Management and across the organization, for example, involvement in training, initiatives, projects, subject matter expert role, leading a CRA team in a trial (National Lead CRA/Global Lead CRA), becoming a recognized expert within country, mentoring. To monitor (including oversight monitoring of CROs) clinical trial activity at investigator sites. To ensure the conduct of high-quality clinical trials according to ICH-GCP Guidelines, LEO Standard Operating Procedures and other regulations and laws as applicable.

Roles and Responsibilities

• Conduct oversight, pre-trial, site initiation, interim and close-out monitoring visits at investigator sites (60% travel with 75% at peak times) as defined by the monitoring guidelines or required by the trial to ensure the conduct of high quality clinical trials according to ICH-GCP Guidelines and according to LEO SOPs.
• Identify and contribute to a database of potential investigators for participation in clinical trials.
• Obtain, review for quality and completeness, and process regulatory, ethics and essential documents from investigator sites.
• Create and maintain appropriate trial-related documentation (including but not limited to the ITF, eTMF, correspondence, visits reports and follow-up letters).
• Create and maintain appropriate national/global site management documents NLCRA or GLCRA, as applicable.
• Ensure that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and A/E and SAE reporting.
• Ensure Serious Adverse Events (SAEs) are reported by the site according to the protocol; ensure full SAE reconciliation has been completed at the site level.
• Manage and report on the progress of the trial at assigned sites,
including communication and escalation of issues, as site CRA or as country NLCRA (or GLCRA), as applicable.
• Review and source document verify CRFs and verify other clinical data for completeness and accuracy; generate queries. Ensure data entry timelines are adhered to by the site.
• Resolve queries in the eCRF database with study site personnel and support colleagues in clarifying queries if required.
• Demonstrate technical competence and assist with user acceptance and implementation of electronic data capture (EDC) and other electronic systems at sites.
• Review tables and listings generated from study data.
• Consult regularly with the investigator at the site concerning recruitment, retention strategies and other matters relating to the trial.
• Liaise with the investigator and site staff to ensure open communication, learning and motivation.
• Perform country level tasks including for example local trial budget presentation and management, local ICF and other subject-facing document development, local clinical trial agreement facilitation (if according to local process), investigator site selection, national coordinating investigator selection, trial feasibility, ethics and competent authority submissions (or assist with, as per local processes)/approvals/filing when in NLCRA role.
• Identify and contribute to a database of potential investigators for participation in clinical trials, as well as providing insights into potential global trial challenges.
• Ensure that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations, and AE and SAE reporting, as well as ensuring the CRA team is adequately trained when in a more national/global role.
• Identify and be pro-active in escalating process and site issues, providing intervention and feedback.
• Attend local and international training, as required, as well as performing some peer-to-peer training where required.
• Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.
• Assist in the training of other CRAs on monitoring, internal LEO processes and procedures, and other duties as required.
• Execute other duties as required by the Head of Global Clinical Operations, Head of Global Site Management or Line Management as training and experience allows, including but not
limited to National/Global Lead CRA role.
Key Working RelationshipsExternal:• KOLs, investigators, clinical research site staff
• IECs/IRBs/REBs and local health authorities
• Partner contract research organization staff and vendors.

Internal:
• LEO staff aligned with local LEO Affiliate
• All Global Site Management and GCO staff, MA, QA, global employees from LEO Headquarters

Job Specific Requirements• Bachelor’s Degree in science or equivalent, or relevant experience in clinical research.
• Minimum 3-5 years’ work experience as a Clinical Research Associate, dependent upon range and nature of work experience.
• Thorough knowledge of ICH-GCP.
• Comprehensive knowledge of local regulatory/ethics environment.
• Excellent written and verbal communications skills; fluency in English, both written and verbal.
• Proficiency in Microsoft Office (Outlook, Excel, PowerPoint), EDC and CTMS systems.
• Ability and willingness to travel 60% with 75% at peak times.
• Valid driver’s license and valid passport (or able/willing to obtain a passport).
• Excellent organizational skills and ability to manage time and work independently, and as a team.
• Able to support CRAs in maintaining quality and in the reporting of quality issues.
Ready to learn more about LEO Pharma?

LEO Pharma has been pioneering medical innovations for more than 110 years. Today, LEO Pharma looks to constantly improve and extend what is possible for the benefit of patients. Our rapidly expanding product portfolio and pipeline includes global therapeutic areas in psoriasis, eczema, skin infections, acne, rosacea and, most recently, rare disease.

LEO Pharma believes in challenging the status quo, so we approach dermatology “beyond the skin.” Our global innovation ecosystem includes internal research & development and digital health via the LEO Innovation Lab.

As we look to shape our U.S. footprint now and in the future, we pride ourselves on our agile and entrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.

 
Perks

We offer a competitive compensation package, 401k match, vision, dental and health insurance, annual bonus, three weeks’ vacation to start, a culture that emphasizes work-life balance, both paternity and maternity leave, an on-site game room, free membership to the on-site gym, plenty of coffee machines and - most of all - a FUN and celebratory work environment.

Let’s wrap this up

If you are interested in joining a small, growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!

At LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.

LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. 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.

Thank you for your interest in career opportunities at LEO Pharma Inc.

LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels:

  • the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite
  • via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com"
  • screening and interaction by telephone and through the Microsoft Teams platform.

Please note:

  • LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
  • Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
  • LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.

Acknowledgement

LEO Pharma reserves the right to make modifications to this job description as deemed necessary by changing position and business requirements.

The job description is a requirement under LEO Pharma's Quality Management System. It does not form part of the employment agreement between the employee and LEO Pharma and cannot be relied on in this respect.

If you have any questions about LEO Pharma Inc. and the application process, please email the company’s U.S. People and Communications team at HRUS@leo-pharma.com.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Wholesale

POST DATE

09/18/2022

EXPIRATION DATE

09/25/2022

WEBSITE

leo-pharma.us

HEADQUARTERS

MADISON, NJ

SIZE

200 - 500

FOUNDED

2009

CEO

JOHN KOCONIS

REVENUE

$50M - $200M

INDUSTRY

Wholesale

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