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 with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
REPORTS TO: Research Manager
DUTIES/RESPONSIBILITIES: (This list may not include all 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.
- 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.
- 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, 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.
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