Summary

Plans, develops, and manages the clinical trials and associated administrative activities of a large, complex medical research study or group of studies. Supervises nursing and/or technical research support staff engaged in the carrying out of research and clinical protocol. Develops budgets, operating procedures, and funding mechanisms, and coordinates the procurement and installation of required facilities, equipment, and materials. Provides direct patient care services as appropriate, and oversees the recruitment, care, and treatment of research subjects.

Duties and Responsibilities

1. Participates in and coordinates the planning, development, and implementation of clinical protocol, administrative and logistical procedures, documentation, and operating systems, in accordance with research parameters set out by the principle investigator.
2. Recruits, supervises, evaluates, and coordinates the activities of a team of professional nurses and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards.
3. Assesses operational, financial, and materials requirements for the study and prepares operating budgets; plans and coordinates the procurement of required clinical facilities, equipment, and supplies.
4. Plans and carries out programs for the recruitment, screening, enrollment, and retention of clinical research subjects and/or volunteers; instructs research subjects on treatment methods and protocol and on the proper administration of drugs and other treatment aids; provides direct nursing care and performs nursing procedures, as appropriate.
5. Establishes appropriate data collection systems and procedures, according to pre-established research protocol; coordinates and monitors the collection, processing, and recording of clinical data and/or specimen samples, as required by established study protocol.
6. Oversees the planning, scheduling, and carrying out of day-to-day clinical activities and procedures, ensuring efficient workflow and adequate care and treatment of research subjects.
7. Develops and/or coordinates the maintenance of records on medication dispensation and inventory usage during the course of the study; ensures confidentiality of subject records.
8. Monitors and records patient response to treatment, and communicates study data and results to investigators; maintains complete source documentation and oversees the preparation of study activity reports for sponsors and various medical, legal and regulatory bodies, as appropriate.
9. Provides consultation, liaison, and administrative coordination between investigators and ancillary departments, research subjects, sponsoring organizations, and/or regulating bodies; identifies and addresses problems, facilitates audits, and corrects deficiencies.
10. Participates in the identification of potential research funding sources, and in the development and writing of grant proposals and project plans.
11. Represents and promotes the objectives and activities of research studies to various internal and/or external constituencies, as appropriate.
12. Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

• Bachelor's degree; at least 3 years of experience directly related to the duties and responsibilities specified.
• Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.

Knowledge, Skills and Abilities Required

• Ability to develop and deliver presentations.
• Knowledge of accreditation and certification requirements and standards.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to observe, assess, and record symptoms, reactions, and progress.
• Ability to maintain quality, safety, and/or infection control standards.
• Skill in the use of personal computers and related software applications.
• Knowledge of the principles and procedures of clinical research.
• Records maintenance skills.
• Skill in budget preparation and fiscal management.
• Knowledge of human resources concepts, practices, policies, and procedures.
• Knowledge of inventory management practices.
• Skill in organizing resources and establishing priorities.
• Knowledge of drugs and their indications, contraindications, dosing, side effects, and proper administration.
• Ability to provide direct nursing care and consultation to patients.
• Knowledge of contracts and grants preparation and management.
• Ability to design and implement systems necessary to collect, maintain, and analyze data.
• Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
• Ability to make administrative and procedural decisions and judgments on sensitive, confidential issues.
• Knowledge of federal, state and/or community funding sources and mechanisms.
• Ability to recruit, evaluate, and instruct clinical research subjects and volunteers.
• Ability to prepare and process laboratory samples using established protocols.
• Ability to develop and manage nursing care plans.

Conditions of Employment

• NM Licensure as a Registered Nurse may be required, as appropriate to the individual position
• Successful candidate must submit to post-offer, pre-employment physical examination and medical history check.
• May be required to submit to annual TB and rubella screening.
• UNM will provide Hepatitis vaccination, candidate may decline vaccination through declination form or may provide record of vaccination from previous employer.

Working Conditions and Physical Effort

• No or very limited physical effort required.
• No or very limited exposure to physical risk.
• Work is normally performed in a typical interior/office work environment.
• Will work with blood or blood-borne pathogens and will require OSHA training.

The University of New Mexico provides all training required by OSHA to ensure employee safety.

Revised Date: 03/20/2017