Careers

As an innovative and growing biopharmaceutical company, RenovoRx is seeking team members with talent and skills to work in an evolving and fast paced environment focused on the shared goal of improving patient outcomes for those undergoing cancer treatment.

Open job opportunities:

Clinical Trial Manager I

Background

RenovoRx, (NASDAQ:RNXT) is an exciting biopharmaceutical company fighting cancer with a novel, logical therapy platform, currently in a Phase 3 registrational trial for its first indication: locally advanced pancreatic cancer.  The Company’s therapy platform utilizes approved chemotherapeutics with validated mechanisms for delivery and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx has secured FDA Orphan Drug Designation for its first two indications: pancreatic cancer and bile duct cancer (cholangiocarcinoma). Previous studies have demonstrated a median overall survival of 27.9 months versus expected survival of 12-15 months in pancreatic cancer patients receiving only intravenous (IV) systemic chemotherapy. The Phase 3 trial is 44% enrolled as of August 15, 2021 and the Company plans to further build out the platform within the next several months.

RenovoRx is a growing and efficient team where the right candidate for this important position, based in Los Altos, CA, will be exposed to many aspects of the study and the business, generally unattainable in larger organizations. The Clinical Trial Manager I position has an opportunity to join a passionate team with the shared vision to make a major impact on the treatment of cancer patients in areas void of significant advancement.

Position Summary

The Clinical Trial Manager I will strive to support the management and execution of one or more clinical trials/programs and be a hands-on professional, who understands a fast-paced start-up environment and can support managing all aspects of clinical development. This will include managing the needs of RenovoRx’s current Phase 3 pancreatic cancer randomized trial, an upcoming Phase 2/3 bile duct cancer trial, and other upcoming oncology trials. Clinical Trial Manager I must be resourceful with excellent problem-solving skills and be able to assist in management with all operational aspects of clinical trial(s)/program(s) including site selection, startup, enrollment, maintenance, and close-out. Additionally, Clinical Trial Manager I will be attentive to detail and able to contribute to deliverables such as writing study protocols, informed consent forms, study manuals and development of SOPs.

Clinical Manager I Responsibilities

  • Overall support in management of multi-center oncology trials conducted by the company, including:
    • Become a subject matter expert on RenovoRx clinical trial protocols.
    • Respond to questions from Clinical Sites regarding protocol and study conduct as they arise.
    • Overseeing patient enrollment including goals and timelines.
    • Overseeing data collection and monitoring.
  • Submissions and communications to/with IRBs/ECs.
  • Work with internal and external teams including, but not limited to, safety, regulatory affairs, statisticians, Data Management, Imaging, and others as necessary.
  • Support coordination with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings.
  • Maintain Clinical Research Project status and support updates to company’s weekly meetings and to management as needed.
  • Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities.
  • Develop and maintain enrollment.
  • Help manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget.
  • Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.
  • Help develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings.
  • Oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).
  • Assist in development of study plans, including aspects of vendor oversight, risk, safety and communication.
  • Assist to proactively identify risks, develop, and implement mitigation strategies.
  • Oversee other clinical studies/goals in the future as determined by the company.
  • Other assignments may be added in the future.

Skills Requirements

  • Proficient in use of a PC.
  • Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook).
  • Knowledgeable of various EDC systems (i.e., MediData).
  • Ability to use standard office equipment (scanner, copier, phones).

Conceptual Skills Requirements

  • Ability to read, analyze, and interpret complex clinical data.
  • Excellent communication skills, organization skills, and diligence.
  • Excellent computer literacy skills.
  • Efficiently prioritize multiple tasks and utilize time management.
  • Ability to collaborate well with a small team and an independent initiative-taker.
  • Ability to take responsibility and support managing multiple projects as well perform the entire spectrum of work as needed.
  • Able to manage large databases and maintaining electronic documents.
  • Ability to work well under pressure and time constraints for competing priorities.
  • Well-developed focus, and teamwork skills.
  • Smart, efficient, and even-tempered.
  • Initiative-taking and able to thrive in a fast-paced, start-up environment.
  • Energetic, forward-thinking, and creative.
  • High ethical standard and appropriate professional image.
  • Analytical ability, technical skills, good judgment, and project management experience.
  • Possess the ability to see a larger picture perspective and is well versed in the different aspects of the company operation.
  • Must have exceptional skills, including motivation and delegation.

Education/Training/Experience Requirements

  • Bachelor’s Degree in life sciences, medicine, nursing, or other health related disciplines.
  • Minimum of 2-6 years of experience in clinical research including oncology experience (sponsor or CRO).
  • At least 2 years clinical trial management experience.
  • Experience in clinical trials and understanding of clinical data analysis within the industry.

Physical and Mental Requirements

  • Sit for extended periods of time using a computer or phone.
  • Share a workspace and maintain good order.
  • Lift up to 20 lbs.
  • Ability to work independently or with others in a small office environment.
  • Ability to travel to clinical sites equal or less than twenty percent of time.

Clinical Research Associate II / Monitor, Oncology

Background

RenovoRx, (NASDAQ:RNXT) is an exciting biopharmaceutical company fighting cancer with a novel, logical therapy platform, currently in a Phase 3 registrational trial for its first indication: locally advanced pancreatic cancer.  The Company’s therapy platform utilizes approved chemotherapeutics with validated mechanisms for delivery and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx has secured FDA Orphan Drug Designation for its first two indications: pancreatic cancer and bile duct cancer (cholangiocarcinoma). Previous studies have demonstrated a median overall survival of 27.9 months versus expected survival of 12-15 months in pancreatic cancer patients receiving only intravenous (IV) systemic chemotherapy. The Phase 3 trial is 44% enrolled as of August 15, 2021 and the Company plans to further build out the platform within the next several months.

RenovoRx is a growing and efficient team where the right candidate for this important position, based in Los Altos, CA, will be exposed to many aspects of the study and the business, generally unattainable in larger organizations. The Clinical Research Associate II position has an opportunity to join a passionate team with the shared vision to make a major impact on the treatment of cancer patients in areas void of significant advancement.

Position Summary

The Clinical Research Associate II (CRA II) is responsible for conducting monitoring activities of clinical sites in compliance with the trial protocol, ICH-GCP/ISO14155, and all applicable local laws and regulations, company policies and quality standards. The CRA II will perform the management of clinical site activities to ensure the collection of accurate clinical data within given timelines. The CRA II will proactively identify, resolve/mitigate, and escalate risks and/or issues, and must be able to collaborate independently with team support. Additionally, when not traveling, the CRA II will conduct remote monitoring, maintain eTMF, ensure data entry, and query resolution for sites, perform Serious Adverse Events (SAE) follow-up until resolution, and any other clinical activities to support the team.

CRA II Accountability

  • Delivering high-quality, timely monitoring reports for Manager approval per Clinical Monitoring Plan timelines.
  • Scheduling remote and in-person site visits for monitoring as required by protocol Clinical Monitoring Plan.
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at sites as dictated by trial protocol, ICH-GCP/ISO 141155, and company requirements.

CRA II Responsibilities

  • Learning and comprehending a complex Phase III oncology study protocol
  • Answering protocol related questions and relaying questions to the study team from sites regarding the protocol
  • Monitoring data with a focus on data integrity and patient safety per protocol and in accordance with regulations.
  • Planning activities for study monitoring and setting priorities by site.
  • Preparing for and conducting study initiation, interim monitoring, and close-out visits at investigator sites.
  • Collaborating with the in-house team to ensure that visit metrics are maintained as required.
  • Gauging the quality of data and addressing quality issues with team members.
  • Ensuring 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.
  • Ensuring SAEs are reported by sites according to the protocol; ensure full SAE reconciliation has is completed at the site level.
  • Obtaining, reviewing for quality and completeness, processing and maintaining regulatory, ethics and essential documents from investigator sites.
  • Providing accurate and timely trip reports and records of hours worked.
  • Managing query resolution with study sites and data management team.
  • Maintaining the project tracking system of subjects and site information.
  • Maintaining contact with investigator sites via telephone calls between visits.
  • Ensuring adherence to study timelines.
  • Identifying and escalating potential risks and identifying retraining opportunities for site study teams.

Skills Requirements

  • Knowledge of the FDA regulations, GCP/ISO 141155, ICH Guidelines, 21 CFR.
  • Highly proficient with MS Office (Word, Excel, Outlook).
  • Knowledge of Electronic Data Capturing Systems and eTMF Systems.
  • Comprehensive understanding of medical terminology, concurrent medications and familiarity with patient records and documentation.
  • Experience providing clinical protocol training or support for site staff.

Conceptual Skills

  • Ability to work well with internal and external customers.
  • Creative analytical person coupled with good judgment.
  • High ethical standards.
  • Independent work skills and time management skills.
  • Excellent organizational skills
  • High diligence and accuracy.
  • Ability to manage, prioritize multiple tasks, and remain focused on personal objectives with minimal direction.
  • Positive, flexible outlook.
  • Strong interpersonal communication skills with the ability to effectively communicate across all levels.
  • Proven ability to work effectively independently and in a multi-disciplinary team.

Education/Training/Experience Requirements

  • Bachelor’s Degree in life sciences, medicine, nursing, or other health related disciplines.
  • Minimum of 5 years of experience in clinical research of which 3 years are in Oncology.

Physical Requirements

  • Position requires travel up to seventy percent.
  • Working in front of a computer for extended periods of time.

Certificates and Licenses

  • A Certified Clinical Research Associate (CCRA) credential certification preferred.

Preferred Experience

  • Experience in a medical device and pharmaceutical/biotech environment preferred.
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