Job Application for Clinical Scientist at Precision for Medicine

Precision for Medicine is looking for an experienced Clinical Scientist to work remotely from the United States.

Job Summary:

The Scientist, Clinical Science Analytics and Insights performs early and continuing scientific review of clinical data in various formats by applying the protocol and/or other applicable references along with oncology standards for the indication being studied to support overall data quality and consistency (clinical sense of the data) allowing for insights to support a continuous risk management approach.

Essential functions of the job include but are not limited to:

Serves on assigned project team(s) reviewing subject data for accuracy per protocol, associated references and oncology standards of care and principles to support overall data quality and consistency (clinical sense of the data)
Develops and maintains a good working relationship with internal and external project team members, serving as an ambassador to promote Precision’s high quality and ethical image in accordance with the company Core Values
Collaborates with and is supported by CSAI-OS management as well as the Medical Monitors to support cross functional departmental communication as applicable on data capture / review trends (e.g., Medical Monitoring, Safety, Clinical Operations, Project Management, Data Management, SAS Programming, Biostatistics, Translational Science, other vendors, etc.) to meet project deliverables in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs
Provides input into project related documentation such as EDC specifications and related completion guidelines, CSAI-Data Review Guidelines, etc. and requires patient review to be coordinated and tracked with other departments as applicable (data management, medical, safety etc.).
Supports the development and User Acceptance Testing (UAT) of data outputs with CSAI-OS Programming (e.g., Smart Patient Profiles, CSAI-OS metrics/trackers, CSAI-OS listings)
Requires the use of various EDC systems and data visualization tools
Assists CSAI-OS Management by serving as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
Provides routine status updates on findings and escalates issues as appropriate with project team and CSAI-OS Management
Assists with identification of quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project
Conducts UAT of CSAI-OS programming output and participates in EDC UAT supporting the CSAI-OS functionality as applicable
Assists CSAI-OS Management to provide review of the protocol from a scientific-operational perspective
May provide indication input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
Assists in the development and implementation of strategy for an integrated data cleaning process between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.)
Reviews and analyses clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on CSAI-OS project specific review guidelines with an emphasis on scientific and clinical sense (e.g., adherence to applicable disease assessment criteria).
Issues and resolves queries in various EDC systems
Communicates effectively with the internal and external project team as applicable and CSAI-OS management to relay data quality issues/findings and implements necessary actions in response to those issues (e.g., CRA and/or site re-training)
Provides study-specific CSAI-OS training for project teams to ensure accurate and consistent collection including re-training as applicable based on review findings
Develops applicable study-specific monitoring/CRA and data review tools as applicable
Participates as applicable in internal and external study-specific team meetings
Serves as a resource to the project team for scientific questions regarding data capture
May review dictionary coding
Establishes CSAI-OS task tracking metrics to monitor trial and team progress towards project goals
Provides routine Project Management updates at macro and micro level
Ensures applicable eTMF documentation related to CSAI-OS is provided and managed including version control of CSAI-OS owned documents
Performs other duties as assigned by management

Qualifications:

Minimum Required:

Bachelor’s degree or equivalent combination of education/experience in science or healthcare discipline with proficiency in medical terminology

Other Required:

At least two (2) years in clinical operations and/or, data management or related discipline in either the CRO or pharmaceutical industry and/or experience conducting oncology clinical research as a Study Coordinator, Research Nurse or related discipline, or equivalent, relevant experience and/or demonstrated competencies.
Experience as a Clinical Research Associate (CRA) or Study Coordinator/Research Nurse preferred.
Oncology therapeutic experience required with ability to apply working knowledge (e.g., understanding of clinical and oncology standards of care and associated side effects, biomarkers, etc.).
Experience in the review of data from oncology clinical trials with working knowledge of oncology standards
Experience in phase I, II and III oncological trials preferred.
Experience with electronic data capture systems (EDC) and data visualization tools preferred
Computer proficiency
Working knowledge of FDA & ICH/GCP regulations and guidelines.

Preferred:

Medical related degree, RN, OCN, RPH, PharmD, etc.

Competencies and Skills:

Expected to be able to work remotely with the ability to apply oncology and clinical trial knowledge to the review of subject data with minimal supervision.
Demonstrates a working knowledge of oncology with demonstrated ability to apply this knowledge to various tumor types and oncology standards of care (e.g. proficiency in the application of CTCAE, indication specific treatment guidelines, disease assessment criteria such as RECIST, iRECIST, RECIL, IWG, etc.)
Demonstrates the ability to understand oncology clinical trials methodology, including a working knowledge of protocols and specific indications being studied
Desire to continually learn and keep up to date on oncology standard of care
Resolves project related problems and prioritizes workload to meet deadlines with minimal support
Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
Proficient critical thinking, problem solving and decision making skills with attention to detail
Professional use of the English language in both written and oral formats
Demonstrates, an understanding of the service culture
Strong sense of teamwork
Exhibits high self-motivation, and is able to work and plan independently as well as be highly effective in a remote team environment
Ability to assimilate clinical and technical information quickly
Demonstrates a high level of emotional intelligence
Possesses practical knowledge of IT tools and systems including proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook, EDCs, EMRs and data visualization tools.
Values system and work ethic consistent with Precision Values and Company Principles.
Ability to drive and travel up to 25% domestically and internationally including overnight stays

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$100,000 - $125,000 USD

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