Senior Clinical Research Professional COM Division of Immunology Allergy and Rheumatology

Profile

Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL

 

Founded in 1819, the University of Cincinnati embarks upon its third century - building on the past and defining the future by leading urban, public universities into a new era of innovation and impact through its strategic direction, Next Lives Here. Underscoring the power of creativity, ingenuity, invention and inclusion, what's Next will accelerate our unrivaled momentum, evidenced by eight straight years of record enrollment and rankings that include placement among America's top 100 public universities by U.S. News & World Report. Home to a diverse student body of nearly 47,000 and more than 4,200 distinguished faculty, the university combines its Research 1 (Very High Research Activity) Carnegie Classification with a physical setting that The New York Times recently acclaimed as the most ambitious campus design program in the country.

 

JOB OVERVIEW

The College of Medicine, Department of Internal Medicine, Division of Immunology, Allergy and Rheumatology, is seeking a Sr. Clinical Research Professional to plan, evaluate, and coordinate elements of multiple or complex clinical research trials. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.

ESSENTIAL FUNCTIONS

*Provide direction, instruction and guidance to coordinate research activities including patient screening and recruitment, enrollment and education; ensure protocol procedures have been completed adhering to Good Clinical Practice Guidelines as defined by the Federal Drug Administration (FDA) and serve as subject matter expert. *Coordinate nursing/social work and patient care and/or patient follow-up functions of the clinical study including planning and developing related activities. Provide quality patient care to patients and their families within area of clinical specialty.  *Collaborate with care coordinators, social workers, psychologists, physicians and other appropriate treatment team members in diagnostic formulation, treatment direction, and recommendations. Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities. *Initiate and/or assist with developing and revising policies and procedures for nursing practice. *Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.  *Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency. *Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures. *Work closely with UC and UC Health offices in negotiation of contracts, confidentiality agreements and amendments related to the conduct of research activities. *Work with necessary parties to identify compliance, legal, IP and business/financial risk. Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments.  *Prepare, develop, review and negotiate industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures. *Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepare and maintain FDA applications for Investigational New Drugs (INDs). Maintain regulatory documentation. *Conduct internal audits. *Make and assist in modifying protocols and study documents. *Write reports, business correspondence, and procedure manuals. Create data entry instructions and train data entry specialists. Assist with creation of case report forms. *Database creation, testing, and basic maintenance. *Act as liaison between study personnel and data entry specialists. Perform quality checks on data entered by others. *May serve as a resource person or act as a consultant within area of clinical and/or regulatory expertise. *Perform related duties based on departmental need. This job description can be changed at any time.

MINIMUM REQUIREMENTS

REQUIRED EDUCATION

*Bachelor's Degree must be in a related field. *For nursing focused role, BSN is required.  *Seven (7) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

REQUIRED TRAININGS/CERTIFICATIONS

*For nursing focused role, BSN in the area of clinical specialization, and RN License in State of Ohio.  *For social work focused role, licensure in the area of clinical specialization.

REQUIRED EXPERIENCE

*Three (3) years of related experience. *For nursing focused roles, appropriate clinical procedural experience.

ADDITIONAL QUALIFICATIONS CONSIDERED

*Master's degree. *Experience in an academic or clinical setting in the area of clinical specialization. *Excellent oral and written communication skills *Meticulous source documentation skills *Proficiency in various computer and software applications is ideal *Immunology, Allergy, or Rheumatology experience strongly ideal but not required

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

*Sitting - Continuously

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

 

As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).

 

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.

 

REQ: 69546 

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Company info

The University of Cincinnati
Website : http://www.uc.edu