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8 days old

Medical Monitor, Oncology Clinical Research

Kelly Services
Palo Alto, CA 94301
Kelly Science & Clinical is searching for an Oncologist for a Medical Monitor contract position for our client. Our client is an small CRO that is expanding into the Oncology Clinical Research sector.


**Medical Monitor, Oncology**

**Remote, US based (no sponsorship or relocation available)**

**Long-term contract**

**Part-time (5-20 hours/week)**


**Overview**

Our client is looking to contract with a BE/BC Oncology Medical Monitor, who will be responsible for providing input into the design and conduct of clinical trials, reviewing and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical and protocol related questions. They will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team. Youll report to their Director of Oncology.


**Key Responsibilities:**

- Work as primary Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial.


- Review and analysis of eligibility per inclusion/exclusion requirements of a clinical trial.


- This may include assessment of diagnostic imaging per protocol requirements


- Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators assessment on causality, and applicable regulatory reporting.


- Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.


- Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.


- Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs.


- Develop and/or review operational, medical monitoring, and safety plans for awarded studies.


- Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.


- Lead and/or participate in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies.


- This may include travel, attendance, and presentation at investigator meetings, symposiums, and/or conferences (This is Rare)


- Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB.


- Ensure activities related to SAEs are conducted in accordance with applicable SOPs and regulations.


- Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.


- Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.


- 24/7 emergency coverage for safety-related matters


**Requirements:**

- BC/BE Oncologist with strong leadership skills


-A minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role, required.


- Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.


- Proficient with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-21 Expires: 2022-10-22

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Medical Monitor, Oncology Clinical Research

Kelly Services
Palo Alto, CA 94301

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