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GENERAL PURPOSE OF THE JOB
The Principal Investigator is responsible for the medical oversight in the conduct of human-subjects research and for protecting the safety and welfare of the subjects enrolled in the research.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive. Note that some job functions may be delegated to research staff as appropriate.
- Understand the trial design including its clinical, scientific, statistical, and ethical integrity
- Provide protocol feedback to sponsor/CRO
- Assist in development of protocol design, if applicable
- Read and maintain general understanding of the Investigator's Brochure as it relates to the protocol
Site Preparation and Initiation:
- Oversee the research staff and support appropriate training of the staff in compliance with GCP with the protocol
- Study-Related Activities
- Interpret laboratory values and alerts according to protocol and subject safety, document appropriately
- Provide direct patient care as related to laboratory and clinical findings with subject related to protocol, for patient safety
Adverse Events (AE and SAE):
- Determine causality of expected or unexpected results associated with investigational product
- Document, classify and manage adverse events
- Assure proper medical care and follow-up until resolution or stabilization of adverse events
- Assure follow-up medical care for subjects, if applicable
- Prepare for and respond to sponsor/CRO, regulatory, or internal audits, questions, comments related to PI
Responsbilities and Obligations:
- Conduct research in accordance with the clinical trial agreement
- Facilitate or verify formal approvals according to ICH GCP and any regional or local requirements
- Oversee progress reports to the IRB at least annually, and as requested
- Ensure compliance with ICH GCP and any regional, state and federal requirements
- Maintain communication with the IRB regarding continuing review, SAE, IND safety reports, protocol amendments, protocol deviations, ICF modifications, final reports, and changes to investigator agreements
- Maintain current knowledge of clinical research issues
- Follow HIPAA regulations
- On-call as required
- Weekend site coverage for HP and drug dosing
- Subject Management
- Participate in the selection of trial subjects
- Assure subjects meet inclusion/exclusion criteria for protocols
- Ensure compliance with data protection
Provide clinical services as direced by protocol:
- History and physical
- EKG read
- Clinical care for patient safety
- Ensure the protection of human subjects
- Explain study to subject
- Assess subject understanding of study requirements
- Obtain all required signatures
- Document obtaining consent in source documents
- Perform and/or supervise the conduct of study-related procedures and monitor the safety of the trial subjects and research staff
- Manage and motivate the research staff
- Establish and maintain professional relationships with trial subjects
- Facilitate effective communications with sponsor, IRB, institution and regulatory authorities
- Documentation and Administration
Case Report Forms:
- Review inclusion/exclusion criteria
- Collect accurate and verifiable data and other essential study documents (i.e. Medical History, Primary Physician follow-up)
- Data entry and validation as required by PI or Sub-I role per protocol
- Review other medical history as it relates to the patient and the protocol
- Assure query resolution with the sponsor.
- Maintain progress notes.
- Document communication with study contacts.
- Document protocol deviations.
Here is what you can expect when you join our Village:
- A "community first, company second" culture based on Core Values that really matter.
- Clinical outcomes consistently ranked above the national average.
- Award-winning education and training across multiple career paths to help you reach your potential.
- Performance-based rewards based on stellar individual and team contributions.
- A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
- Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.
Education, licenses, certifications, and experience required to fulfill the essential duties, include computer skills as required.
- College Degree (B.S. or M.S.) AND
- Graduated from an accredited Medical / Osteopathic School (MD/DO)
- Current DEA License (Not required for all Investigators)
- Current State License (Minnesota)
- Prefer 4 year practical clinical experience
ESSENTIAL BEHAVIORS, SKILLS, AND ATTITUDES REQUIRED FOR SUCCESS IN THIS POSITION
- Commitment to and role model of DaVita's values of Service Excellence, Integrity, Team, Continuous Improvement, Accountability, Fulfillment and Fun with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions
- Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately in an evolving work environment with shifting time frames; self-starter with high degree of initiative, urgency, and follow through
- Innovative, analytical thinker with demonstrated ability to perform root cause analysis, prepare and implement action plans, and lead improvement initiatives
- Demonstrated ability to create, refine, and manage new business processes
- Willingness and desire to create a team learning environment and to foster a positive, fulfilling work environment
- Demonstrated ability to balance department efficiency and field service excellence
- Willingness to assist teammates in order to achieve departmental goals
- Demonstrated strengths in teambuilding and leadership skills
- Demonstrated willingness, desire, and ability to supervise with aptitude for coaching, mentoring, training, and developing teammate performance and skills required
- Demonstrated ability to lead and motivate teammates with confidence in work processes and goals
- Ability to maintain open and clear communication with teammates
- Demonstrated desire and willingness to train new teammates and provide ongoing mentoring and coaching; able to coach teammates to achieve continuous improvement
- Ability to maximize resources to accomplish key metrics
- Strong written, verbal, and interpersonal communications skills including ability to listen attentively and to communicate information clearly and effectively
- Demonstrated ability to work well with cross-functional groups
- Demonstrated interpersonal, collaborative, and relationship-building skills; ability to interact positively with teammates at all levels across the company
- Approachable and open
- Demonstrated ability to communicate difficult or sensitive information tactfully
- Demonstrated proficiency in consultative skills when addressing inquiries
Fluent in the written and verbal skills necessary to perform successfully the essential functions, duties, and responsibilities of the position.
Vision adequate to perform essential duties and responsibilities of position.
Physical requirements can vary. These must be reviewed with management. However, in general, the position requires the following physical activities:
- Ability to lift minimum of 2 pounds to a maximum of 25 pounds unassisted; able to sit, stand, stoop, walk, stretch, reach, lift; full range of body motions
- Ability to hear and interact by phone, in person, and in presentations clearly and efficiently
- Ability to use computer and all peripherals as needed to meet goals
LEVEL I - Job required tasks routinely involve a potential for mucous membrane or skin contact with blood, body fluids, tissues or potential spills or splashes. Use of appropriate personal protection measures is required for every healthcare provider in these positions Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen
Why wait? Explore a career with DaVita today. Go to http://careers.davita.com to learn more or apply. To learn more about our Village and the world of dialysis, click here.
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