Research Compliance Analyst

Description

•  Assists Research Compliance Manager (RCM) and IACUC Coordinator (IC) as needed to facilitate protocol preparation across all oversight committees in an effort to maintain open communication with faculty, lab managers and research staff during review processes.
• Assists in the development and maintenance of the electronic protocol systems related to the IACUC, IRB, IBC and ESCRO Committees.
• Conducts IACUC grant congruencies/audits to compare, verify and ensure consistency of sponsored projects related to the oversight of all oversight committees.
• Assists in organizing the IACUC semi-annual facility inspections. Assists in resolving deficiencies by maintaining communication with Veterinarian staff, animal resource management facility managers and research staff to ensure that required corrective actions are completed in a timely manner.
• Works in collaboration with RCM and IC to ensure successful program accreditation to include but not limited to AAALAC accreditation. Prepares reports as needed. 
• Assists in investigation process related to IACUC non-compliance and post approval monitoring (PAM) overall which may include animal welfare concerns as directed by RCM and/or IC.
• Assist in updating compliance related policies, standard operating procedures as needed.
• Assist RCM in vetting researcher requests to obtain human biological material/samples to determine whether they meet the definition of human subjects research.
• Takes IACUC and IBC compliance committee meeting minutes at convened meetings and assists with follow up.
• Continuously acquire and maintain working knowledge of subject matter related to regulatory compliance topics (via internet, webinars, etc.).                                                      

• Assists in tracking and monitoring use of controlled substances to include, but not limited to, reviewing returned log sheets, scanning logs into database, emailing lab staff when documentation is missing, working with lab staff to ensure drugs are returned prior to expiration.
• Assists in the tracking and monitoring of precusor chemicals to include, but not limited to logging orders, maintaining intended use statements, and preparing annual summary reports.
• Schedules annual Controlled Substance audits which includes working with Lab Managers/Coordinators, setting the inspection schedule, working with other EH&S staff to adhere to the schedule, and generation of biennial inventory reports.

• Conducts the EH&S New Hire (NEO) Orientation/training on a rotation schedule with EH&S staff, contributes to content/updates to training module as needed, routinely collaborates and shares information with EH&S staff regarding overlapping issues such as but not limited to: risk assessments related to hazardous materials and/or infectious agent work in animals, vaccinations, facility signage, facility inspections, documenting EH&S autoclave program, biosafety concerns, active participant in annual emergency response planning and drill, etc.

• Minimum 2 years of relevant experience, to include experience in a research setting managing or processing laboratory protocols and/or in a regulatory compliance role.

• Minimum 2 years of relevant experience, to include, but not limited to, working with the IACUC and or animal resources in a biomedical research setting, compliance related responsibilities in a vivarium, experience in post approval monitoring and/or in a research setting working with animals.
• Experience working in a department or work-related setting that monitored state and federal compliance a plus.

•  Bachelor’s degree or equivalent combination of education and experience.

• Bachelors degree in compliance related field (i.e. regulatory, environmental compliance, public health, etc.), is a plus.
• Experience working with research animals in a biomedical setting. (i.e. in a vivarium setting, managing an animal colony, providing animal related services to research staff, etc.).

• Ability to function independently and manage priorities and time effectively with minimal supervision.
• Performs effectively in environments with frequent workload changes and competing demands, ability to meet deadlines.
• Ability to learn new tasks and functions quickly, accurately, and efficiently as new projects arise.
• Ability to set priorities which accurately reflect the relative importance of job responsibilities.
• Excellent communication skills both verbal and written with all levels of faculty, staff, administration and a broad array of individuals. Ability to communicate with tact, good judgement, diplomacy, and flexibility to relate to a diverse scientific research and administrative staff.
• Ability to work within cross-organizational teams, work collaboratively with individuals and groups from a wide variety of backgrounds and organizational levels, to actively listen to other’s ideas, to be inclusive of other’s needs, to contribute effectively and to find consensus whenever possible to meet project goals.
• Detail oriented, excellent organizational and multitasking skills.
• Ability and interest in continually looking for ways to contribute ideas and suggestions in the area of document creation, updates and administrative process improvement.
• Proficient in MS Office, including Word, Excel and PowerPoint; Adobe a plus.
• Proficient computer skills. Ability to learn site specific applications (i.e. Cayuse/eSirius animal protocol database, internal Salk databases for IRB, ESCRO and IBC).
• Ability to recognize and maintain confidential information.
• Knowledge of related federal, state and Salk Institute policies, procedures and regulations.

•  Must be willing to work in an animal-related research environment.
• Able and willing to work in laboratory settings that may contain biological, chemical, radioactive materials and/or research animals.
• May be involved in matters of high confidentiality related to non-compliance and/or employee complaint(s).
• Successful completion of the Institute’s background investigation.
• Must be willing to sign a confidentiality agreement.
•  Will be subject to medical surveillance requirements to work in animal facilities, including but not limited to:
•  TB Testing/Clearance (every 12months / once a year)
• Hepatitis B (proof of immunization and/or vaccination)
• Tetanus (vaccination < 10 years)
• Measles (proof of immunization and/or vaccination)
• May be required to wear a respirator and complete a respirator fit test and respirator clearance exam
• Other vaccines/tests as required by Occupational Health & Safety standards