Summary

Plans and manages the various clinical trials operations of a major research component of the UNM Health Sciences Center. Oversees and coordinates data management and reporting for multiple industry-sponsored clinical trials, ensuring compliance with sponsor requirements, associated regulations, and IRB guidelines. Oversees the execution of clinical protocol and patient care associated with clinical trials. Participates in the development and implementation of clinical trials policies and procedures, and in strategic interactions with sponsors and potential sponsors.

Duties and Responsibilities

1. Oversees the planning, implementation, and administration of industry-sponsored clinical trials, ensuring compliance with sponsor requirements and associated legislation, regulations, guidelines, and polices governing the conduct of human subject research.
2. Prepares and submits comprehensive reports to funding agencies, regulatory bodies, and other interested parties.
3. Directs and coordinates the collection of clinical research data, ensuring that all processes are in compliance with sponsor and regulatory requirements, guidelines, and policies; participates in strategic advisement and decision making with regard to data collection operations.
4. Participates in and follows up on the identification of and interaction with potential funding agencies of clinical trials; makes recommendations and participates in decision making regarding the establishment of working arrangements.
5. Trains staff and serves as a primary advisor and resource regarding compliance with research sponsor and regulatory agency requirements; reviews operations as appropriate and prepares compliance reports.
6. Plans and implements programs for the recruitment, screening, enrollment, and retention of clinical research subjects and/or volunteers; instructs or oversees instruction of research subjects on treatment methods and protocol, and in the proper administration of drugs and treatment aids.
7. Ensures accuracy, completeness, consistency, and compliance with study guidelines of source documents, case report forms, adverse reactions reports, and related documents; identifies and corrects descrepancies, and provides corrective internal and external training as appropriate.
8. Oversees the provision of direct nursing care and the performance of nursing procedures, as appropriate to the study.
9. Plans, coordinates, and reviews the development and maintenance of comprehensive and detailed study records and logs, and oversees the preparation of study activity reports for funding agents and various medical, legal, and regulatory bodies, as appropriate.
10. Oversees the supervision of personnel, which includes work allocation, training, promotion, enforcement of internal procedures and controls, and problem resolution; evaluates performance and makes recommendations for personnel actions; motivates employees to achieve peak productivity and performance.
11. Develops or assists with the development and implementation of policies and procedures consistent with those of the organization to ensure efficient and safe operation of the unit.
12. Participates in development, implementation and maintenance of policies, objectives, short-and long-range planning; develops and implements projects and programs to assist in accomplishment of established goals.
13. Provides consultation to, and liaison/coordination between investigators, ancillary departments, research subjects, sponsoring organizations, regulatory bodies, University Hospital, and the Clinical Trials office.
14. Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

• Successful completion of at least 60 college-level credit hours; at least 7 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

• Knowledge of all federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
• Ability to communicate effectively, both orally and in writing.
• Program planning and implementation skills.
• Knowledge of laboratory and clinical practices as related to the conduct of clinical trials.
• Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
• Knowledge of clinical studies sponsored by private companies and industrial standards pertinent to clinical trials.
• Ability to develop, plan, and implement short- and long-range goals.
• Ability to evaluate statistical information and make sound judgments.
• Knowledge of statistical data collection, analysis, tracking, and reporting systems, methods, and techniques.
• Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
• Knowledge and understanding of sound principles, methods, systems, and processes for controlled clinical trials involving human subjects.
• Ability to foster a cooperative work environment.
• Strong interpersonal skills and the ability to effectively communicate with a wide range of individuals and constituencies in a diverse community.
• Advanced verbal and written communication skills.
• Knowledge and understanding of the nature, guidelines, standards, and operating requirements of Institution Review Boards
• Employee development and performance management skills.
• Ability to foster effective working relationships within a team environment.
• Ability to read, understand, and evaluate patient charts, patient histories, treatment plans, and other medical records.
• Advanced critical thinking skills and ability to take appropriate corrective action.
• Knowledge of principals, procedures, regulations, guidelines, and standards related to clinical research/medical records management.
• Knowledge of faculty and/or staff hiring procedures.

Conditions of Employment

• National certification from Association of Clinical Research Professionals or Society of Clinical Research Associates is required to oversee Phase III clinical trials.
• New Mexico licensure as a Registered Nurse may be a requirement for some positions in this classification.

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.

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

Revised Date: 03/20/2017