Senior Clinical Research Associate (Remote Position)

Davita Inc.; United States; Remote; USD 103,000 - 193,000; Full time

Job summary

A leading healthcare services company seeks a Senior CRA for remote work across the U.S. This role requires overseeing clinical trials, ensuring compliance with regulations, and entails 80% travel. The ideal candidate has a BS/BA degree and at least 3 years of site monitoring experience. Competitive salary and comprehensive benefits package are included.

Benefits

Health benefits

401(k) with company contribution

Generous time off package

Qualifications

• Minimum of 3 years' experience in site monitoring strongly preferred.
• Oncology and Neuroscience monitoring experience highly desirable.
• Excellent knowledge of the drug development process.

Responsibilities

• Serves as the primary site manager for assigned clinical investigative sites.
• Ensures compliance with protocol, GCP, and local regulations.
• Identifies, resolves & escalates issues appropriately.

Skills

Clinical Research

Communication

Data Integrity

Decision Making

Life Science

Education

BS/BA degree (Scientific or healthcare discipline preferred)

Tools

Clinical Trial Management Systems (CTMS)

Job description

Job Description Summary

This is a Remote Based position. Candidates must be located near an airport (Northeast- highly desirable location). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country.

The Senior CRA is responsible to deliver data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs.
LI-#Remote

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel.

Job Description

Your Key Responsibilities:

Trial Monitoring strategy:

* Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)

Allocation, initiation and conduct of trials:
* Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
* Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
* Facilitates the preparation and collection of site and country level documents
* Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required.

* Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.

* Accountable for continuously updating all relevant electronic systems to perform job functions

* Takes on the responsibility as SME (Subject Matter Expert) as needed

Delivery of quality data and compliance to quality standards:

* Monitors studies as per current legislations, ICH/GCP and Novartis standards
* Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.

* Identifies, resolves & escalates issues appropriately
* Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry

* Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities

*Partners with SSU CRA to ensure seamless transition of site responsibility

Role Requirements:

BS/BA degree. Scientific or healthcare discipline preferred
* Minimum of 3 years' experience in site monitoring strongly preferred

* Oncology, Neuroscience monitoring experience highly desirable

* CAR T and/or RLT experience a plus!
* Excellent knowledge of the drug development process specifically clinical trial/research
* Knowledge of international standards (GCP/ICH, FDA, EMEA)
* Ability to manage multiple priorities and manage time efficiently.

* Excellent Site management capabilities with demonstrated negotiating and problem-solving skills

* Strong communicator and presentation skills (oral and written)

* Fluent in both written and spoken English

The salary for this position is expected to range between $103,600 and $192,400 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.

COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [e-mail].

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$103,600.00 - $192,400.00

Skills Desired

Clinical Research, Clinical Study Reports, Clinical Trial Management Systems (CTMS), Clinical Trials, Clinical Trials Monitoring, Communication, Data Integrity, Decision Making, Life Science