Research Associate-Dept. Of Orthopaedic Surgery LSU Health Shreveport

Job Overview
The Research Associate (RA) will work directly under the Director of Clinical Research. The RA will facilitate and coordinate the daily aspects of clinical trials. They will work closely with the Institutional Review Board (IRB) in making sure studies are properly reviewed. The RA will also assist with maintaining the quality of ongoing studies. The RA will work closely with the undergraduate students, medical students, and residents as part of a team of researchers. The RA will assist with submission of research projects to peer reviewed journals and keep up to date with all current submissions to journals.

The RA will coordinate/prepare presentations of research to annual meetings for orthopaedic surgery related research. The RA will assist in resident and medical student meeting registration and presentations. The RA will also assist in collaborative projects with the LSU Ortho Biomechanics lab and Tissue Regeneration lab.

This person must be able to work independently and to establish priorities for the on-going work of this office. The work hours are generally Monday through Friday from 8:30a.m. to 5:00p.m. Additional hours may be required.

Regular attendance is required to perform the functions of this position.

Incumbent will maintain a customer-oriented awareness in acknowledging and responding to needs as they occur that customer satisfaction is met at all times.

Essential Position Functions & Duties

50% Protocol Management

• Adhere to the requirements of assigned clinical trial protocols.
• Assist the investigator, Director, Business Manager, and other clinical research personnel in pretrial evaluation, cost certification, and budget and contract preparation.
• Actively participates in subject recruitment.
• Review all eligibility criteria and follow-up requirements and screen patients according to criteria.
• Educate patients about the purpose of the clinical trial and study procedures.
• Assure consent process is completed and documented.
• Enroll eligible subjects who have signed consent on study.
• Coordinate pretreatment and follow-up tests, ancillary department material submission, study drug supply, and patient scheduling as needed.
• Collect and submit data on appropriate forms according to the protocol.
• Ensure treatment plans are carried out correctly and adhere to protocol guidelines.
• Assure that the most current IRB approved version of the protocol and consent form is sued for patient enrollment.
• Re-consent patients as needed in accordance with all protocol and consent form amendments.
• Review eligibility criteria and source documents submitted by affiliate sites to verify patient eligibility.
• Assist affiliate sites to ensure accurate implementation of protocol procedures. This may include travel to affiliate sites for audit purposes when necessary. This may also include performance of study related duties on mobile screening vehicles.
• Schedules and/or performs procedures such as patient interviews, counseling, collection of vital signs, medication administration, venipunctures, and other specimen collection within the privileges granted by the incumbent’s license.
• Report Adverse Events according to the National Cancer Institute (NCI), sponsoring agency and local IRB by completion and submission of appropriate forms.
• Prepare patient charts for quality assurance audits and be present at audits.
• Communicate with Coordinator of Research Studies Billing and assist in accurate billing for study charges.
• Identify which study drugs are supplied by the study, order drugs in a timely manner in order to ensure that patients are treated with study supplied drugs, and alert research pharmacist when such drugs are being ordered for a study.
• Conduct close out procedures for pharmaceutical studies including preparation of patient charts for final monitor visit, notification of IRB personnel and assisting the Coordinator of Research Billing in final disposition of charges.
• Complete and maintain written record to document the flow of data.
• Maintain research records to include, but not limited to, flow sheets, pre-study forms, treatment forms, toxicity forms, serious adverse event forms, off-study forms, eligibility checklists and informed consent.
• Identify and flag copies of source documentation in the research record.
• Provide accurate, complete, legible, and timely documentation on protocol specific forms consistent with source documents for the life of the subject or as long as protocol dictates.
• Accurately document Toxicities and Response Assessments.
• Monitor drug dose calculations and follow laboratory results to ensure dose modifications are made as needed.
• Identify any treatment modification or alteration between protocol study and the treatment administered.
• Explain variances or lack of protocol adherence.
• Assist affiliate sites in accurate completion of case report forms.
• Assist affiliate sites in completion and timely submission of all study patient queries.
• Assure that a system of drug accountability and documentation is maintained.
• Order and coordinate research drug shipments from the NCI or other suppliers of investigational drugs.
• Appropriately return or dispose of drugs as indicates per protocol or standard industry practice.
• Ensure appropriate storage and handling of study drugs as per protocol or standard industry practice.
• Assure maintenance of drug transfer forms, return forms, and shipping receipts.
• Review Investigational Drug logs, Drug Accountability Review Forms, and inventories with pharmacy staff and study monitors.

4. Assure compliance with research regulatory bodies.

• Maintain documentation according to the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) and the Institutional Conference on HARMONIZATION Consolidated Guidelines (ICH).
• Adhere to IRB policies, procedures, and ethics for the protection of human research subjects.
• Communicate with affiliate sites that operate under the LSUHSC-S IRB and ensure that sites are using current approved IRB documents.
• Adhere to the NCI Investigational Drug Accountability Record Form (DARF) requirements.
• Package shipments of biologically hazardous materials according to OSHA guidelines.
• Adhere to LSU Compliance Program’s’ Code of Conduct.
• Accurately utilize electronic databases and web sites.
• Enter each patient protocol registration in the appropriate electronic databases.
• Update databased on a regular and timely basis.
• Perform SWOG registrations via SWOG web site as allowed per protocol.
• Perform study registrations via sponsor’s web site as required per protocol.
• Regularly access web site to assure current information being used.
• Participate in electronic database training and continuing education.
• Review and adhere to electronic database updates and policy changes.
• Assist affiliate sites in the operation and maintenance of the electronic database.

20% Clinical Care

• Specialty focus on the care of research participants
• In addition to providing and coordinating clinical care, clinical research coordinators have a central role in assuring patient safety.
• Care reviewed by research participants is driven by study requirements an the collection of research data as well as clinical indications.
• Study procedures may include administration of investigational drugs, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment or phenotyping to characterize the natural history and etiology of a disease, or delivery of a psychosocial intervention.
• Additional clinical care may be necessitated by the response of the participant to the study intervention.

10% Communication

• Communicate with patient, significant other the healthcare team and external agencies.
• Consult and collaborate with physician/faculty investigators and the interdisciplinary healthcare team to follow treatment protocol.
• Collaborate on a regular basis with Coordinator of Research Studies Billing to assure an accurate record of patient procedures and to identify which are research related or standard care.
• Serve as the primary point of contact between the investigator and the patient and patient families, and keep patient informed of all protocol treatment issues.
• Respond effectively and quickly to situations.
• Establish effective working relationships with other departments as needed.
• Confer with outside physicians and other healthcare team members to obtain data as required.
• Coordinate monitoring activities with physician/faculty investigators, protocol representatives and the Director of Clinical Research.
• Develop effective communication with patient, significant other and/or family.
• Collaborate with the Business Manager regarding financial aspects of the studies.
• Maintain communication with affiliate sites in support and assist in their continued education of the research process.

10% Education

• Plan and provide educational activities for patients, significant others, and staff members.
• Plan and provide patients with educational materials supplied by the protocol sponsors.
• Implement educational activities based on identified needs.
• Educate patients of protocol changes affecting their welfare.
• Actively participate as a preceptor for new coordinators.
• Assist with the continuing education of the healthcare team associated with the care of cancer and other patients.
• Maintain and enhance own knowledge base.
• Attend site initiation visits and investigator coordinator meetings
• Consult Regular attendance at Clinical Research Staff Meetings and Clinical Research Committee Meetings.
• Complete mandatory educational requirements as required by your license.
• Obtain and maintain research certification.
• Develop and maintain an understanding of policies and standard, including but not limited to Southwest Oncology Group, Institutional Review Board, Standard on the Commission of Cancer, and Joint Commission on Accreditation of Healthcare Organizations and hospital and clinic policies.
• Attend mandatory yearly Campus Education Daty and hospital or clinic in-services as appropriate.

5% Quality Assurance

• Performs quality assessment/improvement functions.
• Prepare and present data relevant to identified records selected for quality assurance site visits.
• Clarify issues identified by auditors.
• Implement audit recommendations timely as appropriate.
• Perform periodic self-audits comparing data sheets with medical record for accuracy.
• Periodic review of drug storage and Drug Accountability Review Forms to assure compliance with NCI regulations.
• Report deficiencies to appropriate staff.
• Answer all queries and requests timely and accurately.

5% Marginal Functions

• Performs other related duties and special assignments as director by supervisor.
• Attend investigator meetings as required.

Qualifications

Applicant must meet the following qualification(s):

• Medical doctorate (MD, DO, or equivalent) from an accredited institution, or a third- or fourth-year medical student who has completed their anatomy courses

Additional Position Information

PSN/PER Number: PSN 28019/PER 263

Salary Range: $35,000 - $55,000

Primary Location: Shreveport, LA (on-site position)

About the School

The LSU Systems Office has provided LSU Health-Shreveport employees with excellent benefit options designed with you and your dependents in mind. Our Benefits Section is available between 8:00 a.m. and 4:30 p.m., Monday through Friday, to help answer any questions you might have about these benefits.

• Salary is commensurate with experience and training
• Generous Health, Dental, and Vision Insurance
• Life Insurance
• Long-Term Disability Insurance
• Accidental Death & Dismemberment Insurance
• Flexible Spending Account
• Optional Retirement Plans

Apply Here: https://www.lsuhsc.edu/shv/CareerOpportunities/Home/Detail/5537

Job Type: Full-time

Pay: $35,000.00 - $55,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• No weekends

Education:

• Doctorate (Required)

Ability to Commute:

• Shreveport, LA 71103 (Required)

Ability to Relocate:

• Shreveport, LA 71103: Relocate before starting work (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: In person

Salary : $35,000 - $55,000