Sr Clinical Research Prgm Coord
4 weeks ago
Summary:
Reporting to the Lifespan Clinical Research Center - Research Nurse Manager and in accordance with established departmental policies and procedures is responsible for representing the Lifespan Clinical Research Center to industry sponsors regarding the implementation operations and auditing of sponsored clinical research projects. The Sr. CRPC works collaboratively with the entire study team to manage workflow and monitor outcomes ensuring productivity and timely attainment of project goals. Responsibilities include clinical trial operations maintaining data management knowledge and expertise maintaining oversight of the day-to-day project management of assigned projects and the mentoring/development of clinical research colleagues.
Responsibilities:
Consistently applies the corporate values of respect honesty and fairness and the constant pursuit of excellence in improving the health status of the people of the region through the provision of customer-friendly geographically accessible and high-value services within the environment of a comprehensive integrated academic health system. Is responsible for knowing and acting in accordance with the principles of the Lifespan Corporate Compliance Program and Code of Conduct.
Ensures that research is conducted in accordance with the approved protocol Good Clinical Practice and guidance established by the Lifespan Research Protections Office (RPO).
Participates in interview selection and evaluation of other research staff. Provides for training and orientation to project. Coordinates work schedule monitors adherence to procedures/protocols to ensure optimal patient participation rates accurate data collection timely follow up and recommends corrective action as appropriate.
Organizes and oversees the assigned protocols of the project provides direct services as outlined by the protocols. Assists in coordinating clinical research projects including preparing submissions to the IRB regulatory document compilation coordination with inpatient and outpatient staff; assists as research assistant and provides training to other research assistants to perform related activities which may include: review records identify patients meeting eligibility criteria establishing and maintaining research records for study participants review medical records to abstract information preparing visit summary sheets compliant with the protocol administer standardized tests and entering data into computerized database.
Resolves problems and monitors reports from sponsors.
Coordinates collaborative work with other investigators and/or sites.
Maintains quality assurance in accordance with established hospital department policies and objectives.
May require travel to other sites.
Maintains and enhances professional expertise through educational opportunities and review of pertinent literature.
Collaborate with investigators and nursing staff on project feasibility and implementation of proposed projects through assessment of logistical requirements based on current research environment. Troubleshoot and develop new capacities as needed for innovative clinical trial requirements.
Fulfill the role of lead trainer for non-nursing clinical staff. Act as a mentor to junior colleagues and clinicians new to clinical research within the Lifespan system in the successful operational launch and completion of assigned projects. Mentors and assists CRA staff in the execution of study responsibilities.
Promote the role and relationship of the Lifespan Clinical Research Center across Lifespan department affiliates and with study sponsors through participation in meetings symposiums and presentations by acting as a representative of LCRC.
Maintain/continue to develop technical aptitude in the functional operation and implementation of clinical trials by attending Sponsor led instructional training conducting literature reviews and attending conferences to facilitate knowledge-based relationships with non-Lifespan domestic and international colleagues.
Maintain regulatory knowledge of FDA requirements/guidelines regarding clinical trials to support alignment with national and international research standards.
In partnership with department leadership identify additional needs for development of departmental methods or procedures and act accordingly. Provide edits/revisions to departmental policies and procedures as necessary.
Monitor the financial health of projects by reviewing account information in Data Watch and OnCore. Prepare send and track invoices to sponsors and LCRC clients.
Actively participate in and/or perform external/internal system audits to ensure 21CFR departmental regulatory compliance. Coordinate and/or conduct annual awareness training in these areas.
Maintain oversight of the day-to-day operations of assigned projects.
Other information:
EXPERIENCE:
Three years progressively more responsible and related experience in the research field.
Demonstrates effective working knowledge of Microsoft Office programs use of teleconferencing programs and competencies necessary to interact with older adults with knowledge of aging processes and cognitive impairment.
Technical knowledge/aptitude and the demonstrated ability to develop investigational biologic and medical devices.
Strong organizational and communication skills required.
BASIC KNOWLEDGE:
BA/BS in related field. Related previous experience coordinating research studies.
Able to utilize electronic medical records systems/Epic REDCap and CTMS as needed.
Previous human subjects research experience
Ability to prioritize tasks.
Interpersonal skills to effectively interact with patients families MDs and hospital professionals.
WORK ENVIRONMENT:
While most duties are performed in an office environment risk of exposure to contagious or noxious elements is minimized by adherence to safety procedures and protocols. Some tasks are conducted in a laboratory environment with possible exposure to human biofluids (e.g. blood) and chemical reagents.
INDEPENDENT ACTION:
Functions independently within a broad scope of department policies and practices; generally refers specific problems to supervisor only where clarification of departmental policies and procedures may be required.
SUPERVISORY RESPONSIBILITY:
None.
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