Clinical Research Coordinator

Why work for Nebraska Methodist Health System?
At Nebraska Methodist Health System, we focus on providing exceptional care to the communities we serve and people we employ. We call it The Meaning of Care - a culture that has and will continue to set us apart. It's helping families grow by making each delivery special, conveying a difficult diagnosis with a compassionate touch, going above and beyond for a patient's needs, or giving a high five when a patient beats a disease or conquers a personal health challenge. We offer competitive pay, excellent benefits and a great work environment where all employees are valued! Most importantly, our employees are part of a team that makes a real difference in the communities we live and work in.

Job Summary:
Location: Methodist Physicians Clinic - Westroads Office Park III
Address: 1120 N. 103rd Plaza - Omaha, NE
Work Schedule: Monday through Friday, hours between 8am - 5pm

**This position is on site only and not able to be offered as remote**

Coordinates clinical research studies of investigational medications, including but not limited to: regulatory compliance, study start-up phase, implementation of study, follow-up of research subjects, closeout of study, and study record maintenance. Conducts registry studies for data collection and observation (short and long term). Ensures proper billing services. Evaluates and ensures proper follow-up care is provided for all research subjects.

Responsibilities:
Essential Job Functions

1. Trial Management- Clinical or Device

• Verifies investigator/site feasibility, facilitates site budget/contract approval process, and develop timelines for conducting and completing the trial, as well as manage financial agreements.
• Attends Investigator Meetings as required.
• Prepare and submit initial study submission to IRB/IEC and/or sponsor for review and approval.
• Select the investigational staff and assign roles and responsibilities, ensuring appropriate training of staff.
• Maintain trial master file (e.g., regulatory binder), Identify minimum regulatory document requirements for site trial master file (e.g., country-specific regulatory documents), while ensuring IRB/IEC review/approval of study and study documents.
• Develop and follow a recruitment strategy and study management plan, maintain screening/enrollment log and ensure trial subject retention.
• Select and manage local vendors (e.g., laboratory, x-ray, MRI), and maintain current vendor credentials (e.g., lab certification/licensure and normal ranges) as applicable.
• Prepare study documentation (e.g., schedule of events, description of procedures) as well as modifying per protocol amendments require.
• Search clinical databases for potential participants, and schedule participants for protocol specific procedures, including multi-department visits as indicated in protocol.
• Conduct informed consent, working with the participant's the trial Investigator and/or Primary Care Physicians to ensure the participant understands study design.
• Collect, record, and report accurate and verifiable data, conducts participant visits according to requirements, documenting protocol deviations/violations and implementing corrective actions plans as applicable.
• Enter and transmit data, as well as review and resolve CRF queries from the study monitor/data management.
• Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO ensuring timely review of study data (e.g., laboratory results, x-rays).
• Manage study supplies (e.g., lab kits, case report forms), equipment (e.g., calibration and preventive maintenance), and study record retention and availability.
• Coordinate study monitoring visits, including site initiation, interim and close-outs.
• Prepare study documents and study summary and/or close-out letter for IRB/IEC.
• Interrogate implantable cardiac devices (i.e. pacemakers, defibrillators).
• Analyze implantable cardiac devices, perform diagnostic tests, and make appropriate device programing changes.

2. Trial Oversight

• Ensure adequate site management, while being compliant with electronic data requirements (e.g., electronic health records, eCRF).
• Ensure access to source data by authorized parties, in accordance with ICH-GCP, and protect confidentiality by limiting unauthorized access.
• Respond to or facilitate response to audit/inspection findings.
• Ensure proper adverse event reporting by the investigator.
• Escalate problems to appropriate in-house management.
• Investigate and/or report potential fraud and misconduct.
• Ensure follow-up medical care for study subjects is documented, as applicable.
• Ensure staff, facility, and equipment availability throughout the study.
• Ensure compliance with study requirements and regulations.

3. Safety

• Assess participant safety during trial participation, by reviewing participant's medical records, as well as self-reported adverse events.
• Collaborates with physicians and nurses to coordinate a patient's plan of care to prevent duplication of patient services and to ensure continuity of care.
• Minimize potential risks to subject safety, oversee safety risks (e.g., clinical holds, product recalls), handle medical monitor oversight.
• Report required adverse events to Sponsor/CRO, regulatory authorities, and/or IRB/IEC, ensure proper documentation of adverse events, coding correctly (e.g., serious, severe, moderate, mild, expected, unexpected, and causality).
• Ensure reasons for subject discontinuation are documented (i.e., causes, contact efforts).
• Manage and motivate the investigational staff and other disciplines involved, and take measures to minimize any potential risks.
• Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements.
• Review common laboratory values and alerts, review for potential subject safety issues (e.g., toxicity, significant lab values).
• Implement Investigator's plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject).
• Maintain follow-up to determine resolution of adverse event.
• Document follow-up medical care for study subjects, as applicable.
• Conduct safety monitoring/reporting activities.
• Initiate un-blinding procedures.

4. Protocol

• Evaluate and review protocol for feasibility, review protocol during Investigator's meeting.
• Possess knowledge of protocol development, submission, and approval process, including protocol amendment submission and approval procedures.
• Understand clinical trial phases, study design characteristics, (e.g., double-blind, crossover, randomized), and study objective.
• Verify the eligibility of potential trial subjects, reviewing inclusion/exclusion as defined by the protocol.
• Execute study per protocol, following description of procedures (e.g., vitals, blood collection, EKG).
• Ensure proper collection, processing, and shipment of biological specimens (e.g., centrifuge, preparation of slides, freezing, and refrigeration).

5. Investigational Product Management

• Ensure adequacy of investigational product and other supplies at site.
• Ensure randomization and emergency codes of investigational product have been maintained.
• Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies.
• Reconcile, maintain, prepare, dispense, and retrieve investigational product.

Schedule:

Work Schedule: Monday through Friday, hours between 8am - 5pm

**This position is on site only and not able to be offered as remote**

Job Description:
Job Requirements

Education

• Associates degree in healthcare discipline or relevant field required.
• Bachelor's degree preferred. Will consider relevant work or educational experience.

Experience

• A minimum of 1 year of experience with clinical trials and/or regulatory experience required.

License/Certifications

• Certified Clinical Research Coordinator (CCRC) required within 3 years of employment.
• International Air Transport Association (IATA) Dangerous Goods Regulation (DGR) training required within 30 days of hire.
• Collaborative Institutional Training Initiative (CITI) program certification required within 30 days of hire.
• Current American Heart Association Basic Life Support (BLS) strongly preferred at time of hire, required within 3 months of hire.

Skills/Knowledge/Abilities

• Knowledge of research study design for clinical trials, Phase I - IV.
• Knowledge of medical terminology, cardiac anatomy, physiology, and conduction system.
• Knowledge of Good Clinical Practice (GCP) regulations/guidelines and federal regulations surrounding the conduction of human research.
• Knowledge of HIPAA guidelines, legal and ethical considerations related to patient and company information.
• Skill in effective written and verbal communication.
• Skill in operating office equipment including a personal computer, EMR, practice management system, scanner/fax/copy machine, pager and telephone systems.
• Skill in obtaining vital signs and performing phlebotomy services.
• Skill in query resolution.
• Ability to conduct trials under the direction of a Principal Investigator.
• Ability to recruit and consent patients according to appropriate guidelines.
• Ability to establish and maintain effective working relationships with those contacted outside of HC in the course of daily work.
• Ability to organize time and materials effectively achieving department goals.
• Ability to accurately type 40 WPM.
• Ability to work collaboratively with physicians, managers, and other staff in a professional manner to promote effective team building.

Physical Requirements

Weight Demands

• Medium work - Exerting up to 50 pounds of force

Physical Activity

• Not necessary for the position (0%):
  • Climbing
  • Crawling
  • Kneeling
  • Sitting
• Occasionally Performed (1%-33%):
  • Balancing
  • Carrying
  • Crouching
  • Distinguish colors
  • Keyboarding/typing
  • Lifting
  • Pulling/Pushing
  • Repetitive Motions
  • Stooping/bending
  • Twisting
• Frequently Performed (34%-66%):
  • Balancing
  • Carrying
  • Crouching
  • Distinguish colors
  • Keyboarding/typing
  • Lifting
  • Pulling/Pushing
  • Repetitive Motions
  • Stooping/bending
  • Twisting
• Constantly Performed (67%-100%):
  • Grasping
  • Hearing
  • Reaching
  • Seeing/Visual
  • Speaking/talking
  • Standing
  • Walking

Job Hazards

• Not Related:
  • Electrical Shock/Static
  • Radiation Non-Ionizing (Ultraviolet, visible light, infrared and microwaves that causes injuries to tissue or thermal or photochemical means)
• Rare (1-33%): - Radiation Alpha, Beta and Gamma (particles such as X-ray, Cat Scan, Gamma Knife, etc)
• Occasionally (34%-66%):
  • Physical hazards (noise, temperature, lighting, wet floors, outdoors, sharps) (more than ordinary office environment)
  • Equipment/Machinery/Tools
  • Explosives (pressurized gas)
• Frequent (67%-100%):
  • Chemical agents (Toxic, Corrosive, Flammable, Latex)
  • Biological agents (primary air born and blood born viruses) (Jobs with Patient contact) (BBF)

About Methodist:

Nebraska Methodist Health System is made up of four hospitals in Nebraska and southwest Iowa, more than 30 clinic locations, a nursing and allied health college, and a medical supply distributorship and central laundry facility. From the day Methodist Hospital was chartered in 1891, service to our communities has been a top priority. Financial assistance, health education, outreach to our diverse communities and populations, and other community benefit activities have always been central to our mission.

Nebraska Methodist Health System is an Affirmative Action/Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other classification protected by Federal, state or local law.