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CLINICAL RESEARCH COORDINATOR
The Clinical Research Coordinator (CRC) is a specialized research professional working in support of clinical trial execution and management. The CRC will support, facilitate and coordinates daily clinical trial activities happening at our preferred site location(s). This individual will work with the site PI, associated departments, sponsors, and institutions to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. See below for details.
CLINICAL DATA SCIENTIST
The clinical data scientist reports to the VP of Data Strategy and works with project staff and corporate leadership to develop and manage databases and analytics products relevant to clinical trials, such as electronic medical records, medical claims, research site capabilities and staff, and the clinical research pipeline. At Patient iP this role is vitally important to the creation of data products used by our clients to plan and execute clinical research trials. See below for details.
PROTOCOL FEASIBILITY ANALYST
This role coordinates the collection and analysis of metric-based trial feasibility information to meet the challenging timelines of the proposal process and independent feasibility assessments. The Feasibility Analyst will attend strategy calls and liaise with Business Unit representatives, Medical Directors, Proposal Analysts, and Business Development to review sponsor requirements and clinical research protocols for Requests for Proposals (RFPs) and feasibility assessments. Once requirements are understood, the Analyst will utilize a variety of proprietary, public, and sometimes client-provided data to propose strategies for maximizing clinical trial performance. Lastly the Analyst will prepare compelling presentations and may participate in client meetings to support these strategies. See below for details.
Working with our technology team, establishes network specifications by conferring with users; analyzing workflow, access, information, and security requirements; designing router administration, including interface configuration and routing protocols. See below for details.
CLINICAL RESEARCH COORDINATOR
*Coordination of clinical research and related activities to include recruitment and retention, support for regulations, support for remote and onsite monitoring activities and scheduling of clinical trial activities.
*Understands and supports training and enforcement of study protocols.
*Prepares and disseminates study materials at the request of the PI.
*Supports and reports on protocol compliance at the site; Maintains records in regard to site compliance.
*Attends investigator meetings and maintains appropriate and required study documentation.
*Adheres to study confidentiality requirements and maintains professional composure during challenging situations.
*Understands regulatory policies on both a local and global level and demonstrates leadership in site activities and relate to study compliance and regulations.
*Serves as the site contact in alliance with the PI for both sponsor and contract research organization.
*Pays careful attention to study requirements and serves as a liaison between the site and study personnel.
*Understands process improvement and strives to continuously improve the site processes that best serve study quality and efficiency.
*Works within the confines of finances and time requirements to meet study requirements.
*Keeps the PI informed of study and timelines challenges and works with the study sponsors to resolve challenges in a timely manner.
*Prefer a Bachelor’s degree in a health science discipline or comparable experience in the pharmaceutical research and development industry.
*Healthcare and health data experience preferred.
*2+ years’ experience in a position with similar leadership responsibilities.
*Experience building and optimizing processes that support site performance and compliance.
*Excellent customer communication skills a must.
*Effective listening and speaking in order to maintain a relationship that best supports success of a clinical trial.
*Excellent written and verbal communication skills.
*Ability to interact with patients and health care providers to best explain and facilitate study benefits and risks.
*Understanding of Good Clinical Practices and clinical research standards and policies.
*Strong organizational and planning skills
*Ability to work collaboratively with colleagues and supervisors.
*Displays social perceptiveness and the ability to coordinate actions with others actions.
*Ability to balance multiple projects in a fast-paced work environment.
CLINICAL DATA SCIENTIST
* The Clinical Data Scientist will identify requirements for a project, identify and explain known limitations and risks both early in a project and within the final work products, and provide compelling visual and verbal presentations to explain relevant findings.The Scientist’s key responsibility will be the application of knowledge and skills to read and interpret clinical research protocols to answer business-critical and sometimes complex questions for customers
* Must have the ability to work on cross functional teams that include Patient iP project staff and client representatives, such as medical professionals, data visualization experts, and clinical research professionals
* Candidates must have or desire to grow their knowledge of the clinical research process and the appropriate management of data within this process
* Candidates must also be competent with the phases of clinical research, the role and operations of CROs, pharmaceutical and medical device companies, regulators, and research subjects
* Must have proven experience formulating analysis plans; retrieving and/or merging data from multiple sources; and, characterizing limitations or artifacts within the data
* Candidates for this position have formal education in clinical informatics, computer science, and/or data science
* Experience with ICD-10, SNOMED, LOINC, CPT-4 and others are used in the context of analytics and data quality, and can query repositories of data using a variety of vocabularies
* Candidates must be able to retrieve and manipulate data from various data sources such as common file formats (e.g. SAS, CSV, and Excel), relational databases (e.g. SQL Server, Oracle), and APIs (e.g. XML web services)
PROTOCOL FEASIBILITY ANALYST
* Works independently to assess the level of data required and approaches for RFPs and individual paid feasibility assessments.
* Liaises with other team members to review sponsor requirements, protocol, and timelines for individual RFPs.
* Performs QC and analysis of feasibility data including interpretation for production of feasibility text for proposals and reports.
* Performs research of various data sources using Internet and internal facilities to provide information for proposal development.
* Liaises with internal and external customers to coordinate the collection of feasibility data.
* Provides input for preparation of patient recruitment strategies as required.
* Develops feasibility analysis work processes and supports collection of associated metrics
* Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
* BS/BA in Science with an emphasis in medical research or equivalent education or experience.
* Adept in common medical terminology and medical coding vocabularies commonly used in electronic medical records.
* Nominal experience in Science or related field. Knowledge of principles, concepts, practices, and standards in the CRO industry.
* Excellent time management skills, negotiating skills, and decision-making skills.
* Excellent written and verbal communication skills.
* Good computer literacy skills including word processing, spreadsheet, and database applications.
* Attentive to detail in the analysis and presentation of data.
* Flexible, creative, and open to suggestions.
* Self-motivated and ability to work both independently and as a critical part of a team.
* Ability to work concurrently on several projects, each with specific and unique requirements.
* Evaluates network performance issues including availability, utilization, throughput, goodput, and latency; plans and executes the selection, installation, configuration, and testing of equipment; defines network policies and procedures; establishes connections and firewalls.
* Maintains network performance by performing network monitoring and analysis, and performance tuning; troubleshooting network problems; escalating problems to vendor.
* Secures network by developing network access, monitoring, control, and evaluation; maintaining documentation.
* Prepares users by designing and conducting training programs; providing references and support.
* Upgrades network by conferring with vendors; developing, testing, evaluating, and installing enhancements.
* Meets financial requirements by submitting information for budgets; monitoring expenses.
* Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
* Protects organization’s value by keeping information confidential.
* Accomplishes organization goals by accepting ownership for accomplishing new and different requests.