Clinical Trials Coordinator

Nebraska Hematology Oncology PC; Lincoln (NE); On-site; USD 55,000 - 75,000; Full time

Job summary

Nebraska Hematology-Oncology, PC is seeking a Clinical Trials Coordinator to support a range of oncology/hematology studies. You will coordinate regulatory processes, participant visits, and cross-department activities under the supervision of the Clinical Trials Manager.

The role requires attention to detail, strong communication, and knowledge of SOPs, FDA regulations, and good documentation practices. Experience in clinical research is preferred, bachelor’s degree required.

Qualifications

• Detail-oriented with excellent communication skills.
• Experience interacting with patients, sponsors, and investigators.
• Knowledge of policies, regulations, and procedures for clinical research.

Responsibilities

• Coordinate and participate in clinical research studies led by principal investigators.
• Coordinate regulatory documents, initiation visits, and cross-department procedures.
• Conduct protocol-defined patient visits and informed consent processes.
• Record source data accurately and ensure proper billing of procedures.
• Maintain primary point of contact with study patients and care team.
• Assist in development and maintenance of SOPs related to research.
• Ensure compliance with FDA and regulatory guidelines.

Skills

Detail-oriented

Excellent communication

Interaction with patients and sponsors

Regulatory knowledge

Organizational skills

Safety awareness

Problem solving

Education

Bachelor's degree in healthcare

Research experience

Clinical research certification (CCRC/CCRP)

Job description

Description

JOB TITLE: Clinical Trials Coordinator

JOB SUMMARY: Coordinate and participate in clinical research studies conducted by principal investigator(s) at Nebraska Hematology-Oncology, PC. Coordinate and perform study specific regulatory processes and subject visits across multiple studies of different Oncology/Hematology therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.

REPORTS TO: Clinical Trials Manager

DUTIES/RESPONSIBILITIES

(This list may not include all of the duties assigned.)

• Coordinate and participate in clinical research studies conducted by principal investigator(s) at Nebraska Hematology-Oncology, PC.


• Collaborate with investigators to select appropriate and feasible studies to conduct at Nebraska Hematology-Oncology, PC.


• Complete study initiation procedures which may include: regulatory document submission, study initiation visits, source document creation/review, creation of methods for conducting study-required cross-departmental procedures (such as with laboratory and chemotherapy administration), and storing and organization of all study materials.


• Facilitate and perform continued subject pre-screening, continued reporting and communication with study sponsors and IRBs, and maintenance of the study files.


• Conduct protocol-defined study patient visits, which may include the following procedures: informed consent, continued education of the patient on protocol-specific requirements, facilitation of study lab collection, study lab packaging and shipment, facilitation of chemotherapy administration, dispensing/collection of study drug, scheduling of future patient visits, recording complete, accurate, and contemporaneous source documentation, and ensuring the correct billing of study-reimbursed procedures vs. standard of care procedures.


• Perform study patient vital signs and EKG collection


• Collaborate with outside vendors for scheduling of study patient procedures


• Report the occurrence of adverse events as defined within the study protocol, and complete data entry into sponsor-provided case report forms from source documentation.


• Maintain as a primary point of contact for study patient and communicate subject status/needs with their care team


• Assist in the creation and maintenance of Standard Operating Procedures relating to research.


• Assure compliance of general and study specific processes with SOPs, the FDA, and applicable regulatory agencies.


• Perform other related duties incidental to the work described herein.

Requirements

REQUIRED SKILLS/ABILITIES:

• Applicant should be detail-oriented with excellent communication skills.


• Position will require interaction with patients, study sponsors, the research team, and principal investigators.


• Knowledge of organizational policies, regulations, and procedures to administer clinical research protocols.


• Knowledge of medical terminology.


• Knowledge of common safety hazards and precautions to establish a safe work environment.


• Skill in identifying problems and recommending solutions.


• Skill in preparing and maintaining records, writing reports, and responding to correspondence.


• Skill in developing and maintaining department quality assurance.


• Skill in establishing and maintaining effective working relationships with patients, medical staff, and the public.


• Ability to maintain quality control standards.


• Ability to react calmly and effectively in emergency situations.


• Ability to interpret, adapt, and apply guidelines and procedures.


• Ability to communicate clearly.


• Knowledge of safety requirements and ability to recognize and correct hazardous conditions.

Education/Experience

• Completion of a bachelor's degree in a field related to healthcare preferred.


• Research experience preferred.


• Alternative to Minimum Qualification: Clinical research certification, i.e. CCRC or CCRP with relevant clinical and/or research experience.

Physical Requirements

• Requires full range of motion including manual and finger dexterity and eye-hand coordination.


• Occasionally lifts and carries items weighing up to 30 pounds.


• Requires corrected vision and hearing to normal range.