Senior Clinical Research Associate (CRA)

Job Description Summary

This is a remote position where candidates must be located in Florida. 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 for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs.

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

LI:#Remote

Internal job title: CRA II

Location: Remote (Florida)

Job description

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

• 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 ensuring thorough documentation in Monitoring Visit Reports

• 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

• 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

Essential Requirements:

• Minimum of 3 years’ experience in site monitoring

• BS/BA degree. Scientific, Healthcare or other related field.

• 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

Desirable Requirements:

• RLT, CAR T or Oncology experience a plus!

The salary for this position is expected to range between $108,500 and $201,500 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.

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 Eh.occupationalhealth@novartis.com.

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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$108,500.00 - $201,500.00

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences