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CLINICAL RESEARCH MONITORING SPECIALIST SR

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Posting Details

Posting Details

Reference Number 40-27250
Posted Job Title CLINICAL RESEARCH MONITORING SPECIALIST SR
School Name Perelman School of Medicine
Org CI-Center for Cellular Immunotherapy
Posted to the Web 11/13/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8-5
Months 12
Position Length Contingent Upon Funding
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Senior Clinical Research Monitoring Specialist is responsible for performing GCP monitoring activities for sponsored IND clinical research trials to verify human subjects are protected; the data are accurate, complete, and verifiable from source documents; and the conduct of the trial is in compliance with the approved protocol. The Senior Clinical Research Monitoring Specialist will:
* Work closely with the assigned Sponsor Project Manager during study start-up meetings, study site initiation visits, and throughout the study in obtaining all required regulatory documents, sponsor-required documents and assure the site subject and regulatory files are complete and filed in accordance with GCP/ICH requirements.
* Conduct initial, interim and close out monitoring visits according to the study-specific data safety monitoring plan (DSMP), protocol, and other regulatory requirements for all assigned clinical trials following Sponsor Standard Operating Procedures (SOPs) and in accordance with GCP/ICH guidelines.
* Perform source document verification to ensure data entered into the CRF are complete, accurate and verifiable per the protocol and monitoring plan.
* Verify all subjects met protocol-defined inclusion/exclusion criteria for each assigned clinical trial.
* Confirm appropriate documentation pertaining to investigational product accountability, administration and chain of custody at each study site and perform 100% review of these records during all monitoring visits.
* Review and follow-up all SAEs, MedWatch forms, and safety reports to ensure that sites are in compliance with all regulatory reporting requirements.
* Ensure the sites maintain complete investigator site files that include but are not limited to: site ethics committee (IRB) approvals; documentation of qualification of investigators and study personnel; investigator brochure (as appropriate); protocols; case report forms; consent documents; clinical trial material shipping orders; protocol training documentation; and all sponsor and site correspondences.
* Communicate site issues, concerns, and progress to Sponsor Project Manager and follow-up to ensure appropriate resolution of any identified issues.
* Complete visit reports and follow up letters following departmental SOP’s.
* Support sites in resolving outstanding observations documented in a monitoring report.
* Along with the Sponsor Project Manager, work to help develop and implement corrective actions plans, and resolution of monitoring/audit findings when appropriate.
* Participate in site conference calls and meetings to review progress of ongoing clinical trials.
* Participate in development of department and cross functional SOPS
* Work collaboratively with other units in the Translational Research Program, Office of Clinical Research and the Center for Cellular Immunotherapy to ensure data quality, integrity and the protection of the rights, safety and welfare of study subjects.
* Develop and maintain good working relationships with investigators and study staff, serving as an institutional ambassador to promote high quality and ethical standards.
* Adhere with Perelman School of Medicine internal policies and procedures addressing PTO and travel expenses.

Qualifications

A Bachelor’s Degree and 5 years to 7 years of experience, or an equivalent combination of education and experience, are required. Experience in research as either a clinical research nurse, clinical research coordinator or clinical research project manager required. Knowledge of GCP and federal, local, and institutional regulations that apply to the conduct of human research. An understanding of patient charts and medical terminology. Detail oriented. Self-motivated and able to prioritize. A plus having worked in oncology field prior.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Quick Link http://jobs.hr.upenn.edu/postings/32759

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter