Career Opportunities - Clinical Research Coordinator

This Coordinator in the Feist-Weiller Cancer Center at LSUHSC-S is a professional healthcare team member. The incumbent will function as a clinical research coordinator of NCI sponsored cooperative group, industry sponsored, and in-house investigator initiated clinical research trials carried on through the Feist-Weiller Cancer Center. This will include not only treatment trials, but also cancer control and prevention trials as mandated by the NCORP grant award or the Associate Director for Cancer Prevention and Control. Incumbent will be responsible for carrying out work to its completion under general supervision of the Director, Medical Service Area and the faculty investigators conducting the research in the Feist-Weiller Cancer Center. Incumbent will also assist in the conduct of clinical trials at Feist-Weiller Cancer Center's affiliate sites established through its NCORP grant award. Incumbent must have an in-depth understanding of all regulatory guidelines set forth in the Code of Federal Regulations, ICH Guidelines, Good Clinical Practice, I-IIPAA, and the LSUHSC-S IRB and Clinical Trials Office pertaining to the conduct of clinical research in human subjects. Incumbent will act as administrative liaison between the M.D./Ph.D. Principal Investigator and all cooperative groups, industry sponsors, the Investigational Review Board, and all federal regulatory agencies.

Job duties involve specialized work requiring knowledge of the clinical trial process in order to recruit and evaluate appropriate research trial participants. Specific duties include patient recruitment and assessment of patient eligibility, enrollment in appropriate trials, implementation of treatment or other research plans according to protocol guidelines, case management of protocol subjects, management of study drug supplies and drug accountability, education of other healthcare professionals, patients, and families regarding clinical trial participation, timely and accurate collection and submission of research data to clinical trial sponsors, completion of long-term follow-up of study patients, chart preparation for and participation in all quality assurance, FDA, and NCI audits, timely maintenance of in-house patient management database, completion of study queries, compilation, analysis and verification of statistics, initiation of and response to correspondence related to research activities, assistance with training additional affiliate sites in the conduct of clinical trials.

This position differs from a clinical research associate position in that it is focused on the specialty of the patient's clinical care and/or cancer prevention care as well as the protocol driven tasks. In addition to providing and coordinating clinical care, clinical research coordinators have a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, data recording and follow up. Care received by research participants is driven by study requirements and the collection of research data related to clinical indications. Study procedures may include administration of investigational drugs, performance of an experimental or investigational 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.

The incumbent must be able to make independent decisions and establish independent work routine. This will be a dedicated full-time position.

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

Customer Service

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

Essential Functions:

A. 50% Protocol Management

1. Adhere to the requirements of assigned clinical trial protocols.

A. Assist the investigator, Director, Business Manager and other clinical research personnel in pretrial evaluation, cost certification and budget and contract preparation.

B. Actively participate in subject recruitment.

C. Participate in health fairs and cancer screening programs for recruitment of patients to cancer control and prevention trials.

D. Review all eligibility criteria and follow-up requirements and screen patients according to criteria.

E. Educate patients about the purpose of the c 1 inicallrial and study procedures.

F. Assure consenting process is completed and documented.

G. Enroll eligible subjects who have signed consent on study.

H. Coordinate pretreatment and follow-up tests, ancillary department material submission, study drug supply, and patient scheduling as needed.

I. Collect and submit data on appropriate forms according to the protocol.

J. Ensure treatment plans are carried out correctly and adhere to the protocol guidelines.

K. Assure that the most current IRB approved version of the protocol and consent form is used for patient enrollment.

L Re-consent patients as needed in accordance with all protocol and consent form amendments.

M. Review eligibility criteria and source documents submitted by affiliate sites to verify patient eligibility.

N. 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 the mobile screening vehicles.

O. 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 incumbent's licensure.

P. Report Adverse Events according to the National Cancer Institute (NCI), sponsoring agency and local Institutional Review Board (IRB) by completion and submission of appropriate forms.

Q. Prepare patient charts for quality assurance audits and be present at audits.

R. Communicate with Coordinator of Research Studies Billing and assist in accurate billing for study charges.

S. 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.

T. 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

2. Complete and maintain written records to document the flow of data.

a. 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.

b. Identify and flag copies of source documentation in the research record.

c. 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.

d. Accurately document Toxicities and Response Assessments.

e. Monitor drug dose calculations and follow laboratory results to ensure dose modifications are made as needed.

f. Identify any treatment modification or alteration between protocol study and the treatment administered.

g. Explain variances or lack of protocol adherence.

h. Assist affiliate sites in accurate completion of case report forms.

I. Assist affiliate sites in completion and timely submission of all study patient queries.

3. Assure that a system of drug accountability and documentation is maintained.

a. Order and coordinate research drug shipments from the National Cancer Institute (NCI) or other suppliers of investigational drugs.

b. Appropriately return or dispose of drugs as indicated per protocol or standard industry practice.

c. Ensure appropriate storage and handling of study drugs as per protocol or standard industry practice.

d. Assure maintenance of drug transfer forms, return forms and shipping receipts.

e. Review Investigational Drug logs, Drug Accountability Review Forms and inventories with pharmacy staff and study monitors.

4. Assure compliance with research regulatory bodies. 

a. Maintain documentation according to the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) and the Institutional Conference on Harmonization Consolidated Guidelines (ICH).

b. Adhere to the Institutional Review Board (IRB) policies, procedures, and ethics for the protection of human research subjects.

c. Communicate with affiliate sites that operate under the LSUHSC-S IRB and ensure that sites are using current approved IRB documents.

d. Adhere to the National Cancer Institute's (NCI) Investigational Drug Accountability Record Form (DARF) requirements.

e. Package shipments of biologically hazardous materials according to OSHA guidelines.

f. Adhere to LSU Compliance Program's Code of Conduct.

5. Accurately utilize electronic databases and Web sites.

a. Enter each patient protocol registration in the appropriate Feist-Weiller Cancer Center electronic databases.

b. Update databases on a regular and timely basis.

c. Perform SWOG registrations via SWOG web site as allowed per protocol.

d. Perform study registrations via sponsor's web site as required per protocol.

e. Regularly access web site to assure current information being used. 

f. Participate in electronic database training and continuing education.

g. Review and adhere to electronic database updates and policy changes.

h. Assist affiliate sites in the operation and maintenance of the electronic database.

B. 20% Clinical Care

1. Specialty focus on the care of research participants.

a. In addition to providing and coordinating clinical care, clinical research coordinators have a central role in assuring participant safety.

b. Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications.

c. 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.

d. Additional clinical care may be necessitated by the response of the participant to the study intervention.

C. 10% Communication

1. Communicates with patient, significant other, the healthcare team and external agencies.

a. Consult and collaborate with physician/faculty investigators and the interdisciplinary. healthcare team to follow treatment protocol. 

b. Coordinate information and support other Coordinators in the Feist-Weiller Cancer Center.

c. 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 of care.

d. 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.

e. Respond effectively and quickly to situations.

f. Establish effective working relationships with other departments as needed.

g. Confer with outside physicians and other healthcare team members to obtain data as required.

h. Coordinate monitoring activities with physician/faculty investigators, protocol representatives and the Director of Clinical Research.

i. Develop effective communication with patient, significant other and/or family.

j. Collaborate with the Cancer Center Business Manager regarding financial aspects of studies.

k. Maintain communication with affiliate sites in support and assist in their continued education of the research process.

D. 10% Education

1. Plans and provide educational activities for patients, significant others and staff members.

a. Plan and provide patients with educational materials supplied by the protocol sponsors.

b. Implement educational activities based on identified needs.

c. Educate patients of protocol changes affecting their welfare.

d. Actively participate as a preceptor for new Coordinators.

e. Assist with the continuing education of the healthcare team associated with the care of cancer and other patients.

2. Maintain and enhance own knowledge base.

a. Attend site initiation visits and investigator/coordinator meetings.

b. Regular attendance at Clinical Research Staff Meetings and Clinical Research Committee Meetings.

c. Complete mandatory educational requirements as required by your license.

d. Obtain and maintain research certification.

e. Develop and maintain an understanding of policies and standards, including but not limited to, Southwest Oncology Group, Institutional Review Board, Standards on the Commission of Cancer, and Joint Commission on Accreditation of Healthcare Organizations and hospital and clinic policies.

f. Attend mandatory yearly Campus Education Day and hospital or clinic in-services as appropriate.

E. 5% Quality Assurance

1. Performs quality assessment/improvement functions.

a. Prepare and present data relevant to identified records selected for Quality Assurance Site visits.

b. Clarify issues identified by auditors.

c. Implement audit recommendations timely as appropriate.

d. Perform periodic self-audits comparing data sheets with medical record for accuracy.

e. Periodic review of drug storage and Drug Accountability Review Forms to assure compliance with National Cancer Institute regulations.

f. Report deficiencies to appropriate staff.

g. Answer all queries and requests timely and accurately.

F. 5% Marginal Functions

a. Provide coverage for other Coordinators.

b. Travel between the Feist-Weiller Cancer Center and associated participating institutions.

c. Performs other related duties and special assignments as directed by supervisor.

d. Attend investigator meetings as required.

Required Knowledge, Skills and Abilities:

Individual must possess these skills and abilities or be able to explain and demonstrate that the individual can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of skills or abilities and to possess the necessary physical requirements with or without the aid of mechanical devices to safely perform the essential functions of the job.

Degree of Physical Demand Strength Level:

Sedentary Work: Exerting up to 10 pounds of force occasionally, a negligible amount of force frequently to lift, carry, push, pull or otherwise. move objects, including the human body. Sedentary work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Light Work: Exerting up to 20 pounds of force occasionally, or up to 10 pounds of force frequently, or a negligible amount of force to constantly move objects. Physical demand requirements are in excess of those for sedentary work. Even though the weight lifted may be only a negligible amount, a job should be rated light work: (I) When it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time or entails pushing or pulling of arm or leg controls; or (3) when the job requires working at a production rate pace entailing the constant pushing and pulling of materials even though the weight of those materials is negligible. NOTE: the constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.

Physical Demands

Positions: Standing, Walking, Sitting, Stooping

Weigh/ Force:  Lifting, Carrying, Pushing, Pulling

Controls:  Hand /Arm Foot/Leg Motor Coordination, Finger Dexterity, Manual Dexterity, Eye/hand/Foot Coordination

Requires an adequate range of body motion and mobility, with or without accommodations to enable the individual to perform the essential functions of the position and as listed below:

Requires prolonged periods of sitting, standing, occasional bending and stooping, and the ability to carry files, portable computer and other items such as audio-visual equipment weighing up to 15 pounds with or without accommodation.

Requires Talking

Expressing or exchanging ideas by means of the spoken word. Talking is important for those activities in which workers must impart oral information to vendors, department representatives, or to the public. Including those activities in which they must convey detailed or important spoken instruct ions to other workers, accurately, loudly or quickly.

Requires Hearing

Perceiving the nature of sounds. Hearing is important for those activities, which requires the ability to receive detailed information through the oral communication, and to make fine discriminations in sound.

Requires Near Acuity

Clarity of vision at 20 inches or less. This factor is important when special or minute accuracy is demanded and defective near acuity would adversely affect job performance and/or safety of self and others. Vision corrected to 20/20 with visual aids.

Mental and Emotional Demands

Requires the ability to collect and analyze complex numerical and language data and reach logical conclusions. Requires the ability to make independent decisions. Requires the ability to work under stress. Requires the ability to work and cooperate with faculty, students, managers, the public and employees at all levels in order to exchange ideas, information and opinions to facilitate the task at hand. Requires the ability to determine the time, place and sequence of operations or actions.

Working Conditions

Contact with a variety of staff and faculty throughout the institution. Possible confined work area. Possible distracting noise levels. Constant interruptions from phone and coworkers. May require occasional travel, possibly including overnight stays. Normal work hours are 8:00 am to 5:00 pm

Knowledge Requirements

Knowledge of the organization, programs and functions of the LSU Health Sciences Center, Shreveport or similar organization. Knowledge of clinical research operations and concepts.

Machines, Tools, Work Equipment and Work Aids

Requires the operation of office equipment including but not limited to computers, typewriters, printers, telephones, copiers, fax machines, filing cabinets, adding machine or calculator, textbooks and periodicals with or without accommodation.

Contacts Required

Contacts include employees, departmental chairpersons, business manager. hospital staff. Communication with personnel at all levels within the Health Sciences Center is required. Contact may include LSU System officials or satellite campus representatives.

Scope and Effect of Work

Work requires a high degree of expertise in the application of management concepts and principals related to given responsibilities. Management of the essential functions and the recommendations and information dispensed by the successful candidate will have a direct impact in the attainment of the overall objectives of the Feist-Weiller Cancer Center.

Complexity of Work

The work consists of complex duties which have a direct and significant impact on the overall success of the organization. The work involves gathering information, identifying and analyzing issues and developing recommendations to resolve problems of significant importance.

Guidance Received

General and specific guidelines for the essential functions are available from the Manager, Medical Service Area and in the form of LSU regulations, federal and state laws. The incumbent will be required to exercise judgment in determining the applicability of these guidelines and must be capable of taking independent action when necessary.

Supervision Received

Works independently under the general supervision of the Director, Medical Service Area and the faculty level Associate Director of Cancer Prevention and Control.

Supervision Given

The incumbent will be responsible to directly supervise all personnel as assigned by supervisor.

The applicant must meet one of the following:

• Bachelor's degree in Nursing from an accredited program ..
• Associate Science Nursing (ASN) and a minimum of four (4) years clinical and or research experience.
• A minimum of two (2) years of experience working in an in-patient unit within the last 5 years.
• Basic Life Support (BLS) - American Heart Association OR American Red Cross

• RN license.
• Critical- care experience.
• Oncology infusion experience.
• ACLS certification.
• Oncology Certified Nurse (OCN) certification.

PSN/PER Number: PSN 56940/PER 535

Salary Range: $60,000 - $80,000  

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

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.

LSU Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.

• 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

Locate and click on the Apply Online button located at the bottom of the screen, enter your contact information, and upload your resume/CV. If you need assistance applying electronically, please telephone 318-675-5589.

If you are contacted for an interview, please let us know at that time if you will need special accommodations.