The investigator is responsible for personally conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research. The investigator must ensure that all human-subjects research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and requirements.
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.
Site Preparation and Initiation:
- Select the research staff and assure appropriate training of the staff.
- Ensure that a recruitment strategy and study management plan is developed to direct the successful conduct of the trial.
Investigational Product Accountability:
- Receive investigational product from sponsor and inventory supplies.
- Ensure investigational product supplies are kept in a secure location according to required storage conditions.
- Dispense and retrieve investigational product.
- Maintain randomization and emergency codes of investigational product dispensing.
Laboratory and Diagnostic Issues:
- Ensure proper collection, processing, and shipment of specimens, handling all samples according to required standards.
- Interpret laboratory values and alerts according to protocol and subject safety.
- 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.
- Ensure timely completion of data collection tools.
- Assure completed investigational product accountability.
- Assure follow-up medical care for subjects, if applicable.
- Determine disposition of study-related materials per sponsor requirements.
- Prepare for and respond to sponsor/CRO, regulatory or internal audits.
Responsibilities 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.
- Ensure that all required documents are submitted for approval to the IRB.
- Provide progress reports to the IRB at least annually, and as requested.
- Ensure compliance with ICH GCP and any regional, state and federal requirements.
- Maintain communications 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.
- Participate in the selection of trial subjects.
- Ensure compliance with data protection.
- Maintain subject screening/enrollment log.
- Ensure the protection of human subjects.
- Explain study to subject.
- Assess subject understanding of study requirements.
- Obtain all required signatures.
- Provide subject a copy of the ICF.
- 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.
- Administer the investigational product following the randomization schedule and maintain the blind as applicable.
- Ensure that study related procedures and measurements are performed at the required time points, according to the study management plan.
- Enable monitoring activities, provide monitoring space, and meet with the sponsor’s monitor as applicable.
- Prepare the study site for audits and inspections.
- 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.
- Record data into the CRF or other data collection tools.
- Collect the trial data and complete the appropriate source.
- Incorporate applicable historical documents into subject charts.
- Assure access to source data by authorized parties, in accordance with ICH GCP.
- Collect and file essential study documents as required per ICH GCP and other local regulatory requirements.
- 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.)
- Graduated from an accredited Medical / Osteopathic School (MD/DO), Physician Assistant or Nurse Practitioner accredited program; Nephrology specialty preferred but not required
- Current DEA License (Not required for all Investigators)
- Current State License (Minnesota) or ability to obtain within agreed upon timeframe
- Prefer 1-5 year clinical trial experience (Phase I-IV), Nephrology specialty preferred but nor required
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.
DaVita is an equal opportunity/affirmative action employer. As such, DaVita makes hiring decisions solely on the basis of qualifications and experience, and without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability or protected veteran status.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.