Research Operations Manager

Job description

Job Title: Research Operations Manager
Location: Case Main Campus
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 8763
Job Description POSITION OBJECTIVE

The Research Operations Manager will have operational leadership and scientific oversight of the Vision Research Coordinating Center (VRCC) Data Management, Monitoring and Analysis Core. The (VRCC) Data Management, Monitoring and Analysis Core serves as an academic research organization for both sponsored clinical and academic multicenter trials in the areas of ophthalmic clinical trials. The manager will be responsible for the day-to-day operations of funded projects. In addition, the manager will provide scientific (design, measurement, database and analysis) input and oversight of all projects conducted within the Core while securing and maintaining quality in accordance with the applicable standard operating policies, ICH-Good Clinical Practice guidelines and national law(s) and regulations.

ESSENTIAL FUNCTIONS

    Manage and execute research projects, coordination, certifications and analyses within the Core and partnered projects. Provide similar support with research collaborators in partnered projects. Meet regularly with research staff to lead and coordinate the research, evaluation and administrative priorities of the projects. Monitor projects for protocol adherence. (20%)Analysis of datasets. Develop and maintain all data derived from studies. Create and maintain project-specific working data files and prepare necessary documentation of all syntax related to univariate, bivariate, and multivariate analyses using SAS, SPSS, R or similar Statistical Software. Prepare statistical analyses needed for annual reports, including progress reports to funding agencies, Data Safety Monitoring Committees and Institutional Review Board (IRB) renewal reports. (15%)Provide operational oversight and serve an independent leadership role within the Core. Make independent decisions and implement procedures and policies without supervisory consultation. Responsible for scheduling, conducting and reporting on external monitoring visits and managing any internal monitoring and audits from government and funding agencies. (15%)Create, maintain and query databases within RedCap or similar programs. Create custom Informed Consent Forms, surveys, and data access groups. Manage quality control, create custom reports, track data edits and monitor the study data and data entry. Assist in training study personnel at sites on database structure and data entry and upkeep. Clean, lock and export the database for statistical analysis. (10%)Ensure local or reliant IRB approvals are secured and maintained for all sites within all projects within the Core. Assist local coordinators in training, back-up, and support, as knowledge, skills and time allows per the discretion of the VRCC Director. (10%)Oversee the fiscal management of operational and research budgets, including accounts payable if applicable, patient billing and grant expenditures. Monitor and evaluate departmental spending. Draft and negotiate budgets for new grants and sponsored research. Oversee the execution of contracts and budgets. Prepare and distribute the financial reporting to requesting agencies. Seek new business for the VRCC Data Management, Monitoring and Analysis Core. As part of new business partnerships, responsible for grant preparation and timely submission of grant. Develop and execute a marketing plan for the (VRCC) Data Management, Monitoring and Analysis Core. (10%)With the VRCC Director and relevant Principal Investigators, establish goals and objectives for the efficient and timely completion of projects. Review and set priorities, manage trainees and student-related issues as needed, seek and cooperate on future research and staff planning. As the Core expands, interview, hire, orient and supervise research staff, includes conducting annual performance reviews and development, initiating all necessary paperwork, and addressing employee issues and concerns. (10%)As part of new business partnerships, responsible for grant preparation and timely submission of grant. Actively participate in the authorship of projects. Responsible for preparation of abstracts, manuscripts, presentations, reports, publications and posters. (7%)

NONESSENTIAL FUNCTIONS

    Perform basic office duties and procedures and maintain communication with a multidisciplinary team. Provide active leadership and strong organizational skills. Ensure adherence to all hospital and department based policies and code of conduct. (3%)Perform other duties as assigned. (<1%)

CONTACTS

Department: Daily contact with directors, principal investigators, faculty, research and administrative staff for clinical and academic trial operations.

University: Frequent contact with faculty and staff in other departments, administrative offices, research administration, etc., for research purposes.

External: Frequent contact with collaborating institutions including UH, sponsors, and agencies. Frequent contact with 46 national clinical sites and eye banks for clinical trial purposes.

Students: Regular contact with residents, students, fellows, and other trainees for research purposes.

SUPERVISORY RESPONSIBILITY

Responsible for the supervision of Research Assistant 4, Research Assistant 3 as well as hiring and training of any new employees, fellows and/or students.

QUALIFICATIONS

Experience: 8 or more years of experience in the field.

Education/Licensing: Bachelor’s degree in related field required; near completion or already earned Master’s degree in related field which includes biostatistical training preferred.

REQUIRED SKILLS

    Extensive knowledge of ophthalmic clinical trials preferred. Knowledge of clinical research, research concepts and biostatistics. Experience with electronic data capture and storage for clinical research trials.Knowledge and understanding of commonly-used concepts, practices, and procedures within the field of ophthalmic clinical trials.Strong interpersonal skills: ability to work and communicate with various individuals from a broad spectrum of disciplines, technical and educational backgrounds within the department, and university, as well as individuals outside the university. Strong organizational skills: ability to multitask, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and follow-through. Excellent customer service skills: ability to maintain effective working relationships and address the potential and current needs of academic and clinical trial sponsors. Effective management skills: ability to lead, train, work with, and elicit cooperation from team members and staff. Ability to work effectively independently and collaboratively within a team. Ability to work with sensitive information and maintain confidentiality related to data files, records and images. Effective problem-solving skills; must demonstrate, sound judgment and good decision-making. Knowledge of basic business administration concepts and marketing practices is preferred. Proficiency in Microsoft Office (ex: Word, Excel, PowerPoint, Access, Publisher), database applications, biostatistics and internet navigation. Ability to be flexible and work in a diverse, fast paced healthcare research environment 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 customers face to face.

WORKING CONDITIONS

General office working conditions and healthcare environment. At times, may need to work occasional overtime hours and attend meetings outside the office or department.

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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Job No:
Posted: 4/10/2021
Application Due: 5/9/2021
Work Type: Full Time
Salary: