Human Research Specialist

Job Description:

Under the direction of the Team Leader of the Institutional Review Board & Regulatory Team within the Administration Core, the Human Research Specialist is responsible for the daily administration, implementation and management of policies and procedures related to the conduct of human subjects research at the National Institute on Aging (NIA) IMbedded Pragmatic Alzheimer's disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory (https://impactcollaboratory.org/). This includes pre-award regulatory assistance to grant applicants as well as post-award assistance to investigators throughout the life of the study.  Primary functions include tracking Institutional Review Board (IRB) submissions and assisting in their development and maintenance; overseeing scheduling and tracking of Data and Safety Monitory Board meetings, Safety Officer requests and recommendations; serving as a liaison between investigators, sponsors, federal agencies and IRB offices and others in regard to regulatory matters; maintaining standard operating procedures.
 
Section 3: Major Responsibilities

Pre- and post-award regulatory management (50%)
Supporting Actions:  Independently review and validate the Protection of Human Subjects Human Subjects and Clinical Trials (HSCT) form in federal grant applications; guide investigators through IMPACT’s just-in-time and central IRB requirements; perform a pre-review of IRB materials prior to submission and manage any inconsistencies by engaging study teams and/or IMPACT personnel; prepare and submit all IRB materials required for Brown’s involvement on IMPACT studies; monitor IMPACT submissions through the central IRB’s online portal.  Educate study teams about IRB/regulatory issues; participate in consultation meetings, IMPACT administrative meetings and other School of Public Health administrative meetings as needed; serve as a liaison between study team members, the central IRB, local IRBs, federal agencies, and IMPACT personnel. Track all related documents and progress in Smartsheets and other designated project spaces. 

Manage standard operating procedures (20%)
Supporting Actions: Review current SOPs related to regulatory tasks with responsible team members and update as needed; assess gaps and develop new regulatory SOPs as needed; develop and execute a timeframe for their regular upkeep; track SOPs in Smartsheets and disseminate them to the appropriate parties.  

Manage DSMB and Safety Officer activities (20%)
Supporting Actions: track the DSMB and Safety Officer requirements for each IMPACT study; work with NIA to update individual data safety monitoring plans (DSMPs) as needed; coordinate the scheduling and preparation of DSMB meetings; oversee the safety officer vetting process, and safety officer submissions and recommendations, ensuring that the proper documentation gets shared with team members, IRBs, NIA, and IMPACT personnel in a timely manner; track DSMB meeting results and ensure that required actions are fulfilled by responsible parties; perform periodic review of the DSMB charter and DSMP template and work with supervisor, IMPACT leadership, and NIA to make any necessary updates.

Support broader needs within the Administration Core (10%)
 Supporting Actions:   As needs arise, work together with other regulatory team members and IMPACT personnel as a whole to ensure that all regulatory needs are met. This may include adherence to new policies and procedures or ongoing regulatory matters outside of just-in-time, IRB, and DSMB oversight.  

Section 4: Decisions Position is Free to Make
 

-     Prioritize multiple IRB protocols
-     Suggest strategies to enhance regulatory process and training 
-     Suggest strategies to enhance IRB compliance and monitoring
-     Suggest strategies to enhance data sharing strategies and compliance with data management plans 

Section 5: Dimensions
 
-    The NIA IMPACT Collaboratory has a projected budget of over $50 million across 5 years and is made up of 6 administrative and management core teams, and 10 working group core and teams.  It currently maintains more than 8 research supplements, 12 pilot studies, 2 demonstration projects, and 5 career development awards and solicits new applicants twice a year.  To date, the regulatory team has managed over $140,000 worth of IRB submissions to a central IRB.  

 
Section 6: Job Qualifications and Competencies

Education
Required:  Bachelors degree (BA or BS) with at least 3 years’ experience in IRB administration, regulatory compliance, and/or health services research management (or related field)

Experience  
•    Proven ability to handle detailed-oriented and fast-paced environment 
•    Proven ability to manage multiple tasks, set priorities, and meet deadlines
•    Preparation of standard operating procedures
•    Advanced Excel, Powerpoint, and Word skills
•    Experience with organizational databases such as Smartsheets is highly desirable
•    Experience with IRB applications is highly desirable
•    Experience with National Institutes of Health clinical trial grant applications is highly desirable

 
Job Competencies
•    Familiarity with and understanding of the Code of Federal Regulations for the Protection of Human Subjects (‘Common Rule’ 45 CFR 46) 
•    Familiarity with and understanding of the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) as it pertains to the use of electronic personal health information for research purposes
•    Ability to assess inefficiencies in procedures and problem-solve
•    Excellent communication skills (both oral and written) to elicit and disperse information; to present information and communications in a clear and concise manner
•    Strong organizational, administrative, time management and critical thinking skills
•    Ability to meet deadlines in a fast-paced, multi-faceted work environment
•    Flexible, service-oriented and resourceful
•    Ability to organize and prioritize workload in a multi-tasking environment while maintaining careful attention to detail
•    Ability to work with a diverse population and handle confidential information with discretion

All offers of employment are contingent upon a criminal background check and education verification that are satisfactory to Brown University.

In order to maintain 90% or greater universal vaccination rates on campus, all newly hired employees at Brown University must receive the final dose of the COVID-19 vaccine before they begin work and must also receive a COVID-19 booster within thirty (30) days of becoming eligible, unless they are approved for a medical or religious exemption. For more information, please visit the Healthy Brown site. 

Recruiting Start Date:

2022-01-12-08:00

Job Posting Title:

Human Research Specialist

Department:

Center for Gerontology & Health Care Research

Grade:

Grade 9

Worker Type:

Employee

Worker Sub-Type:

Fixed Term (Fixed Term)

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Classification:

Hybrid Eligible

Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Vaccination Requirements:

In order to maintain 90% or greater universal vaccination rates on campus, all newly hired employees at Brown University must receive the final dose of the COVID-19 vaccine before they begin work, unless they are approved for a medical or religious exemption. All employees must also receive a COVID-19 booster within thirty (30) days of becoming eligible. For more information, please visit the Healthy Brown site.

Still Have Questions?

If you have any questions you may contact [email protected] .

EEO Statement:

Brown University is an E-Verify Employer.

Brown University is committed to fostering a diverse and inclusive academic global community; as an EEO/AA employer, Brown considers applicants for employment without regard to, and does not discriminate on the basis of, gender, sex, sexual orientation, gender identity, national origin, age, race, protected veteran status, disability, or any other legally protected status.