Edc Project Manager Jobs in Virginia (NOW HIRING)

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Primary Function/General Purpose of Position

Serve as RN Research (Exempt)Clinical Research Nurse Coordinator for Bon Secours Cancer Institute.

Essential Job Functions:

• Enroll patients in research studies, associating visits / appointments / admissions with research studies and reviewing charges via the Research Billing Report to determine which are billed to Insurance and which are billed to the research study.

Project Management:

• Organize and monitor clinical research observational and data collection studies.

• Serve as Liaison between Bon Secours Cancer Institute, area hospital departments, and sponsoring agencies for multiple clinical trials. Serve as liaison with partner institutions for multi-center (national and international) clinical trials.

• Work with other Bon Secours health system departments participating in clinical research to ensure adherence to study regulations and adequate patient care.

• Set up and maintain process/procedures for ordering tests for patients enrolled in clinical trials (special billing mechanisms, etc.).

• Coordinate/plan patient recruitment, prepare inclusion/exclusion criteria checklist, prepare list of allowed and disallowed medications, and flow sheets (if needed). Set up source document utilizing electronic Case Report Forms (eCRFs), protocol, schedule of visits and tests, and other materials to ensure proper recording of data.

• Routinely interact with physicians, coordinators, clinical trials sponsors, and other individuals / organizations participating in clinical trials regarding patient care and related issues.

• Complete CRFs and other documents at the time data is collected or immediately after the data becomes available. Obtain physician investigator's signature on CRF's, test results, and other documents as required and maintain copy per sponsor requirements after sponsor has reviewed and taken original. Retain completed CRFs and regulatory documents for as long as required by sponsor.

• Review adverse events and other data with Physician Investigators and ensure that information regarding adverse events is noted in documentation as required. Report serious adverse events to the Sponsor and IRB within the required time frame. Ensure all records related to adverse events are maintained on file. If the sponsor is paying for costs outside the scope of the original budget for a serious adverse event which required hospitalization or additional testing, work with Research Manager to ensure all charges related to the SAE are billed to the sponsor.

• Participate inpre-site-qualificationmeetings, site selection meetings, interim monitoring visits, audits, investigator meetings, and complete all training required for each clinical trial.

Human SubjectsResearch/IRB/RegulatoryAdministration:

• Maintain regulatory binders with all required documents.

• Complete paperwork for proper processing of charges, reviewing coding, and approving bills to ensure the correct funder is charged for care of patients enrolled in clinical trials.

• Complete required CITI GCP and human subjects research training, maintaining active certifications on file.

PatientRecruitment/Enrollment:

• Assist PI and Sub-Investigator(s) in identifying patients for possible eligibility for treatment protocols.

• Work with patient service representatives to schedule appointments to evaluate patients for eligibility to participate in various programs to treat cancer.

• Review medical records pertaining to these patients and present to the attending physician for review.

• Review consent form with patients, explaining how charges will be handled (ie, what tests are covered by study, which are standard of care and will be billed to insurance), and answer any questions. Obtain patient's signature on consent form.

• Obtain required medical information from patients, advise patients of visits, assign numbers to the patients as required by protocol, and ensure that all study-related documentation, forms, CRF's, are complete.

Investigational Product (IP)

• Work closely with pharmacy on dispensation of investigational product, including having access to pharmacy system for each clinical trial.

Direct Patient Care

• Educate patients concerning natural history of cancer and its complications. Educate patients concerning the side effects of specific medications and other treatment of cancer.

• Complete study collection forms necessary to evaluate effects of treatment on cancer.

• Answer phone questions for patients concerning possible side effects of the treatments they are receiving as well as complications associated with cancer or any other acute illness. Assess this information and present to attending physicians within the Bon Secours Cancer Institute as appropriate.

• Monitor and report test results as appropriate

• Document in Epic and sponsor designated EDC's as appropriate, communicating observations and findings to PI and attending physicians.

• Triage patient calls, arrange for appropriate care.

• Arrange for special procedures for patients enrolled in clinical trials, including biopsies, ultrasounds, endoscopies, etc.

Completion/Close-out of Clinical Trials:

As each study closes:

• Collect medications from patients, inventory study drugs, return to sponsor.

• Explain to patient how to follow-up for their care when study is completed.

• If patient terminates study early -note the reason for file.

• Complete all CRFs.

• Complete all requests for corrections and return them to Sponsor.

• Complete reports required by Sponsor and send final report to IRB.

• Review regulatory binder, make sure all documents are present.

• Store documents and inform Sponsor of storage location

This document is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. Employees may be required to perform other job-related duties as required by their supervisor, subject to reasonable accommodation.

Licensing/Certification

• BLS Basic Life Support - American Heart Association (required)

• RN license current in Commonwealth of Virginia (required)

Education

• Bachelor of Science Nursing preferred); RN required

Work Experience

• 2 years of nursing experience as an RN (required).

• Oncology nursing experience required.

• Research experience (CCRP Research Certification) preferred

• OCN Professional Research Nursing certification preferred

Other Job Functions

• Adheres to all Bon Secours Mercy Health rules, regulations, and polices.

• Performs other duties as assigned. Assists and supports other departments when needed.

• The individual performing this job may reasonably anticipate coming into contact with human blood and other potentially infectious materials. Individuals in this position are required to exercise universal precautions, use personal protective equipment and devices, and learn the policies concerning infection control.

• Works in a normal office environment where there is no physical discomfort due to dust, dirt, noise and the like.

• Works in a patient care area where there is little exposure to dust, dirt, noise and the like.

• Travels outside the office in all weather conditions.

• All candidates must possess strong communications (electronic and verbal) skills due to the detailed tasks entailed.

Range:

Minimum:$36.42

Maximum: $58.28

Bon Secours is an equal opportunity employer.

As a Bon Secours associate, you're part of a Mission that matters. We support your well-being - personally and professionally. Our benefits are built to grow with you and meet your unique needs, every step of the way.

What we offer

• Competitive pay, incentives, referral bonuses and 403(b) with employer contributions (when eligible)

• Medical, dental, vision, prescription coverage, HSA/FSA options, life insurances, mental health resources and discounts

• Paid time off, parental and FMLA leave, short- and long-term disability, backup care for children and elders

• Tuition assistance, professional development and continuing education support

Benefits may vary based on the market and employment status.

Department:

It is our policy to abide by all Federal and State laws, as well as, the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). Accordingly, all applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, genetic information, or protected veteran status, and will not be discriminated against on the basis of disability. If you'd like to view a copy of the affirmative action plan or policy statement for Mercy Health- Youngstown, Ohio or Bon Secours - Franklin, Virginia; Petersburg, Virginia; and Emporia, Virginia, which are Affirmative Action and Equal Opportunity Employer, please email recruitment@mercy.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact The Talent Acquisition Team at recruitment@mercy.com.