Clinical Trials Coordinator

Nebraska Hematology Oncology; Lincoln (NE); On-site; USD 65,000 - 85,000; Full time

Job summary

Nebraska Hematology-Oncology, PC. is seeking a Clinical Trials Coordinator to support multi-study oncology/hematology trials. You will manage regulatory processes, patient visits, and data entry under the supervision of the Clinical Trials Manager.

Responsibilities include initiating studies, coordinating with investigators, ensuring SOP compliance, and maintaining study materials and communications with sponsors and the care team.

Qualifications

• Detail-oriented with excellent communication skills.
• Knowledge of organizational policies, regulations, and procedures to administer clinical research protocols.
• Knowledge of medical terminology and safety requirements.
• Ability to establish and maintain relationships with patients, the care team, and sponsors.

Responsibilities

• Coordinate and participate in clinical research studies conducted by principal investigators.
• Collaborate with investigators to select appropriate studies to conduct.
• Complete study initiation procedures including regulatory submissions and source document creation.
• Maintain study files and communicate with sponsors and IRBs.
• Conduct protocol-defined patient visits, informed consent, education, lab collection, and dosing administration.
• Record vital signs and EKG collection as required by protocols.
• Coordinate with outside vendors for scheduling procedures.
• Report adverse events and complete sponsor data entry.
• Serve as primary contact for study patients and care team.

Skills

Detail-oriented

Communication

Regulatory knowledge

Medical terminology

Team collaboration

Problem solving

Education

Bachelor's degree in healthcare

Clinical research certification (CCRC/CRRP)

Job 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

• 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.

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.