Clinical Research Manager

Location
California, United States
Posted
11 Jan 2019
End of advertisement period
11 Mar 2019
Ref
81616
Contract Type
Permanent
Hours
Full Time

Stanford University is seeking a LGBTQ Digital Clinical Research Manager to provide leadership and oversight of research activities within a dynamic, cutting-edge LGBTQ/sexual and gender minority (SGM) research program. As part of this program we use a broad definition of LGBTQ and SGM which includes but are not limited to lesbian, gay, bisexual, transgender and queer (LGBTQ) people Within this job, the Research Manager will manage the daily research-related components of The PRIDE Study (see below), including its associated Ancillary Studies. This job offers the opportunity to work with a nimble, fast-paced, community-engaged research team to bring novel and much-needed research to under served and understudied LGBTQ communities. The job involves supervising and coordinating with clinical research staff, faculty, and collaborators all over the country. Core communications will be with a small but growing team that works both on-site and remotely and is highly digitally connected. The job involves managing research operations, including quality management, personnel management, regulatory compliance (such as Human Subject/Institutional Review Board), and fiscal oversight. 

The incumbent Research Manager will be a seasoned management professional who understands how clinical research is conducted, has a passion for social-justice driven research and organizational thinking, is expert with establishing and executing clinical research projects on time and on budget, can assure that high-quality ethical research is conducted out, and has exquisite attention to detail. The ideal incumbent will have experience managing digital studies. The incumbent must be very comfortable with digital communications, project management, writing, editing and organizing research-related paperwork, and simple data analytics. The Research Manager will be responsible for oversight and execution of all aspects of the research process including establishing regulatory oversight (IRB applications), participant recruitment and retention, preliminary data report generation for team and advisory board review, facilitating data transfer and analysis with data analytics team, supporting manuscript writing and submission, and ensuring other project deliverables and dissemination materials (e.g., info graphics/videos/blog posts etc.) are produced in coordination with our community engagement and communications team. The Research Manager will also be responsible for oversight and execution of Ancillary Studies with investigators at institutions across the country. The Ancillary Study management includes processing Ancillary Study applications, data-use agreements, and reporting. Finally, the Research Manager will support grant writing and sponsor reporting as required. The Research Manager will function as a resource for understanding the current state of all of The PRIDE Study’s active research projects (including Ancillary Studies) and moving projects forward. 

The RM will work closely with the PIs (Dr. Juno Obedin-Maliver and Dr. Mitchell R. Lunn) to oversee and implement The PRIDE Study’s core research activities (Annual Questionnaire and Ancillary Studies) and analysis. The RM will support the data-driven dissemination of results. The RM will track activity progress, develop recommendations, and write reports. 

THE PRIDE STUDY

The PRIDE Study is a community-engaged, national, online, prospective, longitudinal general health cohort study of SGM adults. The PRIDE Study aims to improve SGM health through research, community engagement, education, and mentorship and envisions a world with optimal physical, mental, and social health for all SGM people. Since 2015, The PRIDE Study has been studying the health and well-being of sexual and gender minority people with a pilot study from 2015-2017 and then with the longitudinal cohort, which launched in May 2017. Since recruitment into the longitudinal cohort, more than 13,000 people enrolled from all over the United States and its territories. Participants engage with The PRIDE Study through a novel web-based platform and complete personal profiles and questionnaires about their health and lives. Core questionnaires are the Annual Questionnaire (takes approximately 1 hour to complete) and Ancillary studies, which are shorter and focus on a particular health topic. We actively engage participants in all steps of the research process from question generation to analytics and data dissemination. In these ways, The PRIDE Study employs innovative technologies to bridge research gaps in the health of these medically underserved and vulnerable populations. For more information, visit www.pridestudy.org. 

The PRIDE Study - Ancillary Studies 

The PRIDE Study seeks to cover a broad range of health and health care topics that are meaningful to study participants and broader SGM community members. The Ancillary Study mechanism enables deeper investigation into topics not covered by The PRIDE Study’s Annual Questionnaire or health profile data. Ancillary Study applications undergo thorough review by a research advisory committee and a participant advisory committee to ensure that they are scientifically rigorous, ethical, and responsive to community needs. Approximately 14 Ancillary Studies are in process. For more information, visit www.pridestudy.org/collaborate. 

PRIDEnet

PRIDEnet is a participant-powered research network of sexual and gender minorities (SGM) people. PRIDEnet’s purpose is to provide SGM/LGBTQ health research participants broad access to engage with the research process from end-to-end. PRIDEnet is the primary vehicle for community engagement in The PRIDE Study (pridestudy.org), a national, online study of the general health of LGBTQ people. PRIDEnet also conducts LGBTQ community engagement for the All of Us Research Program (joinallofus.org/lgbt). 

Duties include:

  • Hire, orient, train, and conduct performance reviews for staff handling research administration activities. 
  • Monitor staffing levels, and identify adequate coverage for our projects. 
  • Supervise the implementation of and adherence to study protocols. 
  • Educate research staff on established policies, processes, and procedures. 
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical studies.  
  • Modify and develop consent forms for approval by Human Subjects Panel.
  • Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. 
  • Complete annual reports to Institutional Review Board, funders and sponsors (such as the NIH), and as needed other regulatory agencies. 
  • Submit Investigational New Drug applications to the FDA as required.
  • Audit operations, including digital data storage processes and data transfer, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. 
  • Monitor Institutional Review Board submissions, and respond to requests and questions.
  • Provide leadership and expertise in identifying and completing research grants. 
  • Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
  • Lead or chair committees or task forces to address and resolve significant issues.
  • Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. 
  • Analyze trends in recruitment toward stated recruitment goals. 
  • Provide oversight and tracking of all Annual Questionnaire processes including: supporting the review of AQ annual data in coordination with our data analytics team, managing the AQ annual revision process, ensuring the AQ is launched every year on time. 
  • Provide oversight and tracking of all Ancillary Study processes with researchers at Stanford and collaborating institutions including: optimizing the functioning of research standard operating procedures, ensuring timely high-quality completion and review of Ancillary Study applications, ensuring completion of and compliance with data use and data transfer agreements, overseeing data transfer, track Ancillary Study deliverables. 
  • Support the implementation and ensure flawless management of the forthcoming PRIDE Study Question Catalog. 
  • Assist with data analysis, manuscript preparation and submission, scientific presentations, and community-facing materials. 
  • Oversee or execute the tracking of publication, presentations, and other project-specific dissemination products like infographics, videos, and one-pagers in coordination with our community engagement and digital communications team members. 
  • Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Masters or higher degree in clinical research, research administration, or equivalent. 
  • Experience with community-engaged research or collaboration.
  • Knowledge of and experience with managing a team of people, including personnel supervision and review.
  • Knowledge of and experience with budget management for research and reporting to fiscal sponsors.
  • Knowledge of an experience with survey design. 
  • Knowledge of and experience with IRB and other regulatory bodies and required applications and reporting. 
  • Knowledge of the lesbian, gay, bisexual, transgender, queer (LGBTQ) and other sexual and gender minority (SGM) communities.
  • Knowledge of the organization, its achievements, mission, vision, goals, policies, practices, infrastructure, and a strong knowledge of current affairs, and issues in health sciences.
  • Basic knowledge of research software tools (e.g., STATA, SPSS, or SAS, Excel, etc.)
  • Knowledge of and experience with Qualtrics (survey administration software)
  • Interest in community health and social justice.
  • Ability to work with sexual, gender, and racial minority and other marginalized populations and be empathetic.
  • Ability to work with people from different professional settings, including research, community engagement, advocacy, and communications.
  • Ability to work with monolingual Spanish-speaking and other non-English speaking communities.
  • Spanish language fluency would be a plus

EDUCATION & EXPERIENCE (REQUIRED):

  • Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred
  • Additional Required Experience:
  • Experience working with digital/online research and associated data. 
  • Experience with working with and managing multi-site clinical/digital studies.
  • Experience with managing multiple studies simultaneously.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Excellent interpersonal skills.
  • Proficiency in Microsoft Office and database applications. 
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
  • Knowledge of medical terminology. 
  • Demonstrated managerial experience. 
  • Additional Required Knowledge, Skills, and Abilities:
  • Comfort with technology including general computing, web-based applications, and willingness to learn new software as job requires 

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

  • Constantly perform desk-based computer tasks.
  • Frequently stand/walk, sit, use a telephone, grasp lightly/fine manipulation, speaking.
  • Occasionally grasp forcefully, writing by hand.
  • Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
  • Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
  • Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
May require extended or unusual work hours based on research requirements and business needs.