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Research Assistant 3

Employer
Case Western Reserve University
Location
Case Main Campus
Closing date
Jun 28, 2021

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Administrative Jobs
Academic Affairs, Research Staff & Technicians
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Job Details

Job Title: Research Assistant 3
Location: Case Main Campus
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 8887
Job Description POSITION OBJECTIVE

Working under limited supervision and closely with the principal investigator(s), the Research Assistant 3 will coordinate the study activities for the Vision Research Coordinating Center (VRCC) and the Visual Sciences Research Center (VSRC) within the Department of Ophthalmology. Responsibilities may include the recruitment and retention of subjects locally or across sites when functioning as part of a Coordinating Center for a multi-center study, protocol compliance, clinical research activities, regulatory documentation, Institutional Review Board (IRB) submissions, study budget and coverage analyses, human subject protection, execution of clinical research protocol activities within training and certification guidelines and the promotion and growth of the center.

ESSENTIAL FUNCTIONS

    Carry out various clinical research projects (both of a routine and complex, non-routine nature) in the VRCC, coordinate start-up activities including coordination of study initiation meeting with sponsor and compose IRB submissions including IRB research plan and informed consent and other required documents and templates. (10%)Work closely with principal investigator to devise new protocols and standard operating procedures in the Vision Research Coordinating Center. Evaluate adequacy of protocols; identify and draft new standard operating procedures for the VRCC or draft new original protocol-specific study procedures for possible adoption to the entire center. (10%)Manage project timeline required by each assigned study and each investigator for dedicated clinical times that meet the protocol requirements. Implement new study protocols which include coordination of required study procedures, logistics and resources including tracking mechanisms to ensure subject and personnel compliance to study protocols. Implement procedures 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. (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. (13%)Execute clinical research protocol activities (within their experience and as certifications and credentialing allow) such as visual acuity assessment, ocular photography/imaging, management of study medications for study participants and height or weight assessment. For investigator initiated studies, setup and maintain databases such as RedCap, download and analyze data within spreadsheets. Complete study charts for each study participant to meet the standards and requirements of the sponsor, IRB office and FDA with 100% accuracy. (10%)Identify adverse events, submit required documents to sponsor and IRB office, and track study participants for adverse event outcomes. (10%)Mange research documentation for multi-center studies including Personnel Status and Certifications. Develop and submit reports for protocol changes and addenda, safety reports and continuing renewals as required for each ongoing study to the IRB and sponsor as needed. Develop reports and tables documenting recruitment, retention and adverse events of study participants for submission to the investigators and department chair. (10%)Act as liaison between study sponsors, clinical research organizations, clinical research associates (study monitors), clinical practices and institutions that govern the participants enrolled (such as University Hospitals of Cleveland) and IRB office(s) by coordinating proper documents, site visits, providing accurate chart information, adverse event reports, information for data queries, information for internal and/or external audits as required for each study and each study participant. Manage Site and Central IRB and ICF approvals and reviews, master trial file and regulatory binders, protocol compliance, participant tracking, data query and resolutions. (10%)

NONESSENTIAL FUNCTIONS

    Attend annual and sponsor-requested local, national and international meetings. (5%)Facilitate patient access to investigators by serving as the primary contact for all study participants and triaging calls as needed. Coordinate scheduling for non-departmental studies requiring ophthalmic examinations. (2%)Arrange for study participant compensation through the institution or sponsor as agreed upon in study contracts. (3%)Perform other duties as assigned. (2%)

CONTACTS

Department: Regular contact with the principal investigator, chair, supervisor, co-worker coordinators, business manager and grants administrator for coordination of study activities.

University: Frequent contact with other principal investigators, project coordinators to facilitate and promote joint action/ cooperation to achieve immediate operating results and/or resolve management problems when no precise direction is provided.

External: Frequent contact with study sponsor contacts and personnel to furnish, obtain or exchange data/ information, or address concerns. Regular contact with participants to represent the department providing services.

Students: Regular contact with student research assistants in the VRCC to define and assign individual tasks and/or maintain schedules and standards.

SUPERVISORY RESPONSIBILITY

May supervise research students and technicians.

QUALIFICATIONS

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

Education/Licensing: Bachelor’s degree required.

REQUIRED SKILLS

    Professional and effective oral and written skills and strong interpersonal skills required. Must demonstrate excellent writing skills and the ability to work with various individuals within and external to the university.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 (required).Knowledge of good clinical practices (required).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 neededAbility to meet consistent attendance.Ability to interact with colleagues, supervisors and customers face to face.

WORKING CONDITIONS

Typical office and health clinic environment. 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.

Diversity Statement

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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Reasonable Accommodations

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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Organization

Working at Case Western Reserve University

Case Western Reserve University is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case Western Reserve is distinguished by its strengths in educationresearch, service and experiential learning. Located in Cleveland's University Circle, we offer nationally recognized programs in the arts and sciencesdental medicineengineeringlawmanagementmedicinenursing and social sciences.

Student enrollment exceeds 9,800 students, forty percent of whom are undergraduatesFacultyand students hail from more than 90 countries, with academic interests that reach every region of the world. Case Western Reserve, with the support of individuals, corporations and foundations, aids nearly 100 designated research centers.

As a service-oriented institution dedicated to civic leadership, Case Western Reserve seeks individually and collectively to prepare our students to improve the human condition and to direct the benefits of discovery toward a better society. This effort is not limited to the university's classrooms, laboratories, librariesresidence halls and athletic fields, but includes partnerships with many other institutions. We build these partnerships believing that our ability to improve the human condition should begin in our own community.

Case Western Reserve University remains Ohio's top-ranked school among the nation's premier national universities, as ranked by U.S. News & World Report and is the only Ohio institution ranked in the top 50 nationally. We promote a culture of inquiry marked by rigor, creativity, curiosity, innovation, respect, sensitivity and open communication of ideas.

The university supports interdisciplinary partnerships in education and research with numerous faculty holding joint appointments in more than one Case Western Reserve school or department, as well as at neighboring institutions. These relationships launched many of the unique pairings of science, business and liberal arts into the centers and programs that enhance the undergraduate and graduate experience at the university. Our dual degree programs enrich the educational experience for those students who choose to balance the technical requirements of engineering or the sciences with a strong interest in the humanities.

With more than $375 million in research funding annually, the university attracts outstanding undergraduate and graduate students along with renowned faculty whose research has made significant contributions to the way we live and work. Case Western Reserve counts 15 Nobel laureates among our alumni and current and former faculty, including the first American scientist to ever receive the prize.

Our students' experiences in cultural institutions, clinics, social service agencies and industry are not viewed as “extra-curricular,” but create the learning experience that defines a Case Western Reserve education. The university's service programs in the Cleveland Municipal School District have impacted more than 145,000 students with more than 43 signature programs. The university has launched more than 580 community partnerships on the local, national and international levels. Annually the university sponsors Case for Community Day, an event where hundreds of Case Western Reserve employees and students lend their time and talent to targeted community development projects in the Greater Cleveland area.

Our alumni number more than 110,000 and constitute a “who's who” of every profession. Alumni represent one of the university's strongest resources, playing a vital role in campus life through their work as advisors, mentors, friends and advocates.

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