Research Assistant 3

Case Western Reserve University, United States

Updated: 4 months ago
Location: Campus, ILLINOIS
Job Type: FullTime

POSITION OBJECTIVE

Working under limited supervision and closely with the principal investigator(s), provide organizational support for operations of National Eye Institute, foundation, and other funded trials in the Vision Research Coordinating Center (VRCC) within the Department of Ophthalmology and Visual Sciences.  One of the primary studies is the ongoing Diabetes Endothelial Keratoplasty Study (DEKS, principal investigator Lass) which is studying if corneal clarity and endothelial cell loss 1 year following endothelial keratoplasty is superior for donor corneas without diabetes than for those with diabetes. 1420 patients will be enrolled across 28 sites with donors coming from 13 eye banks around the country. Responsibilities will also include the recruitment and retention of subjects locally in ophthalmology trials including the NIH funded COAST Study (Clarifying the Optimal Application of SLT Therapy) and/or other trials performed by investigators within the department. Responsibilities will also include other research coordinator functions locally or across sites when functioning as part of a Coordinating Center for multi-center studies, protocol compliance, regulatory documentation, Institutional Review Board (IRB) submissions, management of participant reimbursement, study budget and coverage analyses, human subject protection, and the promotion and growth of the center.

 

ESENTIAL FUNCTIONS

  • Work closely with the principal investigator or Vision Research Coordinating Center director on the various clinical research projects in the center including the DEKS. Coordinate start-up activities including coordination of study initiation meeting with sponsor, IRB submissions, and informed consent documents following required templates. (15%)
  • Evaluate and recruit study participants through internal chart reviews and physician referral, screen subjects for eligibility by evaluating protocol inclusion/exclusion criteria, interview potential participants, and obtain subject’s informed consent according to Office of Human Subject Protection guidelines discussing the risks, benefits, and alternatives of participating in research. (10%)
  • Implement study procedures and track mechanisms to ensure participant evaluations occur at appropriate intervals and promote subject compliance by providing support and education following the goals and plans established by sponsors, investigators and research manager including managing participant compensation as specified in the Protocol. (15%)
  • Manage study protocols, which include coordination of required study procedures (coordinate ophthalmic examinations, history and physical examinations, laboratory requirements, etc.), use of the institution’s investigational pharmacy, shipment and storage of study medications and supplies, organize certified technicians and photographers, and coordination of investigator schedules. (13%)
  • Gather reports and submit the following as needed to the governing IRB(s) for each ongoing study: protocol amendments, safety reports, deviations, and continuing renewals. (10%)
  • Complete study charts and source documentation and case report completion for each study participant to meet the standards and requirements of the sponsor, IRB office, and FDA with 100 percent accuracy. (10%)
  • Maintain certifications, master trial file and regulatory binders, data query and resolution in a timely manner and participate in internal and/or external audits with study sponsors, clinical research organizations, and clinical research associates (study monitors), as required for each study. (10%)

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    NONESSENTIAL FUNCTIONS

  • Execute minimal clinical research protocol activities (within their experience and as certifications allow) such as simple visual acuity assessment, management of study medications for study participants, and height or weight assessment. (5%)
  • Submit required adverse event documents to sponsor and IRB office and manage tracking of study participant’s adverse event outcomes. (5%)
  • Attend annual and sponsor-requested local, national, and international meetings (2%)
  • Facilitate patient access to investigators by serving as the primary contact for all study participants and triage calls as needed. (3%)
  • Perform other duties as assigned including working with department administrator and practice manager regarding institutional (Case Western Reserve University and University Hospitals) procedures and protocols that need to be followed to ensure research compliance among research staff. This will include assisting with updating the departmental standard operating procedures and the DEKS manual of procedures. (2%)

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    CONTACTS

    Department: Daily contact with supervisor, VRCC Research Associate, and co-worker coordinators to maintain workflow. Frequent contact with DEKS Operations Committee including Study Chair, Coordinating Center Director, Cornea Image Analysis Reading Center Director, and Coordinators for the DEKS eye banks and clinical sites.

    University: Occasional contact with research administration and finance and budgeting personnel.

    External: Frequent contact with multicenter study clinical sites and related personnel, and Data Management and Analysis Center personnel at collaborating institutions such as the Jaeb Center for Health Research in Tampa, Florida.

    Students: Occasional contact with student assistants in the VRCC, and department residents to maintain workflow; address concerns/ problems; make adjustment to work schedules and/or procedures.

     

    SUPERVISORY RESPONSIBILITY

    May supervise students and technicians

     

    QUALIFICATIONS

    Experience: 3 to 5 years of experience in a medical or research setting preferred. Clinical research working with IRB offices or other clinical research enterprises preferred.

    Education/Licensing: Bachelor of Science degree required.

     

    REQUIRED SKILLS

  • Must demonstrate professional and effective oral and written communication skills, and strong interpersonal skills in order to work with various individuals. Ability to distill important information from emails/ phone calls and other written materials.
  • Ability to educate/train staff effectively (required).
  • Ability to manage the coordination of multi-center project within the VRCC ensuring that all federal and local protocol requirements are met.
  • Knowledge of good clinical practices.
  • Strong organization skills: ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and proven ability to successfully follow-through on assigned projects.
  • Ability to work effectively independently and collaboratively within a team. (Must be highly motivated, responsible, dependable and a self-starter.
  • Proficiency in Microsoft Office (ex: Word, Excel, PowerPoint, Access, Publisher), database applications, and with internet navigation.
  • Must demonstrate willingness to learn new techniques, procedures, processes, and computer programs as needed
  • Ability to meet consistent attendance.
  • Ability to interact with colleagues, supervisors, and patients face to face.

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    WORKING CONDITIONS

    Typical office environment. The VRCC suite is located in the University Hospitals Cleveland Medical Center Wearn building 6th floor. The employee will perform repetitive motion using a computer mouse and keyboard to type. This job is performed in an office setting with time spent interacting with patients in the various clinical satellite offices within the University Hospitals Eye Institute. There are no/specific hazards associated with this position

    This position is eligible for hybrid work arrangement up to two remote days per week at the discretion of the department. New employees may begin a hybrid schedule upon approval from the supervisor, successful completion of an orientation period and signing the remote work checklist certification form.

    In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity.  Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.

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    Case Western Reserve University provides reasonable accommodations to applicants with disabilities.  Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Equity at 216-368-3066 to request a reasonable accommodation.  Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.

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