Research Compliance Training Specialist (Administrative Analyst/Specialist Exempt Ii)

Position Summary

Reporting to the Assistant Vice President of Research Support Services, the Research Support Services (RSS) Research Compliance Training Specialist is responsible and accountable for assisting with the oversight of the University's Research Compliance programs to ensure that research requirements remain in compliance with local, state, and federal regulations, industry and University best practices, and internal policies and procedures.

Provides overall guidance and direction for ClinicalTrials.gov related reporting for human subjects' research that involve clinical trials. This includes establishing user accounts for research investigators in the ClinicalTrials.gov Protocol Registration System (PRS). Updating clinical trial study records so that study information is current and accurate. Assisting with results reporting which includes the timely submission of study results. record monitoring ensuring that the information reflects the status of the study and complies with regulations. They notify the responsible party if a protocol record becomes delinquent or is not in compliance with federal regulations. The administrator will also conduct weekly reviews of SDSU-affiliated study records for deficiencies or errors that require correction. Provides ongoing education sessions throughout the year to help users understand the system and comply with federal regulations regularly communicating with investigators regarding federal regulations, record updates, and compliance issues.

In addition, the Research Compliance Training Specialist will manage an intern recruitment and training program. The program requires the creation of a recruiting strategy for undergraduate and graduate students that would be interested in a career in Research Compliance and research administration and operations. The strategy would need to develop clear internship objectives: Before recruiting interns, define clear objectives for the internship program. Determine what tasks and projects the interns will be working on and what skills or qualifications are needed to fulfill these roles. Assess relevant skills: Identify the specific skills and competencies needed for the internship. These might include technical skills, communication skills, research abilities, or proficiency in certain software or tools. Determine availability: Determine the duration of the internship and the number of hours per week the intern is expected to work. Be clear about whether it is a full-time or part-time position. Conduct Regular Check-ins: Mentor and coach interns as they learn and work on projects. Provide guidance, resources, and opportunities for skill development.

The Research Compliance Training Specialist works in close collaboration with research operations units, administrative and scientific leadership to understand research operations and effective processes and practices that demonstrate appropriate execution of compliance regulatory requirements so that they can be incorporated into the internship program.

This is a full-time (1.0 time-base), benefits eligible, permanent/probationary position. This position is designated exempt under FLSA and is not eligible for overtime compensation. Standard SDSU work hours are Monday - Friday, 8:00 a.m. to 4:30 p.m., but may vary based on operational needs.

This position is approved for partial telecommuting with onsite work in San Diego.

Department Summary

Research Support Services is responsible and accountable for overseeing the University's Research Compliance programs to ensure that research requirements remain in compliance with local, state, and federal regulations, industry and University best practices, internal policies, and procedures at both San Diego State University (SDSU) and the San Diego State University Research Foundation (SDSURF). San Diego State University has an enrollment of more than 37,000 students and is home to top-ranked graduate programs in business; engineering; public health; psychology; fine arts; biological sciences; public affairs; education; and speech, language, and hearing sciences. Ranked undergraduate programs include business, engineering, and international business. Increasingly recognized for innovative research, SDSU is establishing itself as one of the leading public research universities. Research funding has more than doubled from a decade ago. Since 2000, SDSU faculty and staff have attracted more than $1 billion in grants and contracts for research and program administration. SDSU Research Foundation is a non-profit, auxiliary organization chartered to further the educational, research, and community service objectives of San Diego State University. SDSU Research Foundation is currently administering approximately 1000 active grants and contracts, and annual revenues approaching $190 million. With 157 central support staff and 2,450 grant and contract project employees, it is the largest auxiliary within the California State University (CSU) system. Since these are two separate organizations there are functions that mirror each other like shipping, procurement, and licensing, yet work closely together.

For more information regarding the Division of Research and Innovation department, click here.

Education and Experience

Entry to this classification requires general knowledge and skills in the applicable administrative and/or program field with a foundational knowledge of public administration principles, practices, and methods. This foundation would normally be obtained through a bachelor's degree and/or equivalent training and administrative work experience involving study, analysis, and/or evaluation leading to the development or improvement of administrative policies, procedures, practices, or programs.

Key Qualifications

• Communication Skills: Effective communication is crucial for managing interns. Should be able to provide clear instructions, offer constructive feedback, and be open to their questions and concerns.
• Mentoring and Coaching: Mentor and coach interns as they learn and work on projects. Provide guidance, resources, and opportunities for skill development.
• Conflict Resolution: Be prepared to handle any conflicts or issues that may arise between interns or between interns and other team members.
• Networking: Encourage interns to network within the organization and connect with professionals in their field of interest.
• Advanced degree in a related field.
• Five years of progressively responsible experience with research, research operations, and/or Research Compliance is preferred.
• Thorough knowledge and ability to apply all relevant Federal, State, and University policies. As well as Federal and State guidance documents related to Research Compliance.

Compensation and Benefits

Starting salary upon appointment is not expected to exceed $6,300 per month. 

Salary placement is determined by the education, experience, and qualifications the candidate brings to the position, internal equity, and the hiring department's fiscal resources.

San Diego State University offers a rich benefits package that constitutes a major portion of total compensation. For more information regarding SDSU benefits, please click here.

CSU Classification Salary Range: $5,022 - $9,083 per month. 

Diversity and Community at SDSU

At SDSU, our diversity gives us power and benefits every single member of our community.

Through our commitment to equity and inclusion, we encourage all members of our community to purposefully learn from one another through open and respectful dialogue and responsible engagement. For more information, click here.

Principles of Community

At San Diego State University, we are a community of diverse individuals who have and represent many perspectives, beliefs, and identities. This diversity lends our community strength, and we commit to creating and sustaining an inclusive and intellectually vibrant environment that benefits all members of our university. 

SDSU's Principles of Community is an aspirational statement that is intended to evolve over time. The statement reflects the ideals we are encouraged to uphold in our interactions with one another. 

Supplemental Information

Initial review of the required application materials, including cover letters and resumes, will begin on November 15, 2023. To receive full consideration, apply by November 14, 2023. The position will remain open until filled.

The person holding this position is considered a 'mandated reporter' under the California Child Abuse and Neglect Reporting Act and is required to comply with the requirements set forth in CSU Executive Order 1083 as a condition of employment. 

San Diego State University is not a sponsoring agency for staff or management positions (e.g., H-1B visa). Applicants must currently be authorized to work in the United States on a full-time basis. Offers of employment are contingent upon the presentation of documents that demonstrate a person's identity and authorization to work in the United States, which are consistent with the provisions of the Immigration Reform and Control Act. 

A background check (including a criminal records check) must be completed satisfactorily and is required for employment. SDSU will make a conditional offer of employment, which may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current SDSU employee who was conditionally offered the position.

SDSU is a smoke-free campus. For more information, please click here.

SDSU is an Equal Opportunity Employer that considers all qualified candidates for employment and does not discriminate on the basis of race, religion, color, ancestry, age, disability, genetic information, gender, gender identity, gender expression, marital status, medical condition, national origin, sex, sexual orientation, covered military and veteran status, or any other protected characteristic or status. Reasonable accommodations will be provided for qualified applicants with disabilities who request an accommodation by contacting Pang Thao at pythao@sdsu.edu.