Clinical Trials Coordinator

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.