University of Pennsylvania CLINICAL RESEARCH COORD B in Philadelphia, Pennsylvania
CLINICAL RESEARCH COORD B Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.
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Reference Number 40-28306
Posted Job Title CLINICAL RESEARCH COORD B
School Name Perelman School of Medicine
Posted to the Web 06/07/2018
Posted Job/Salary Grade 026
Employment Type Exempt
Position Type Full Time
Position Schedule 8:00am-5:00pm
Position Length Contingent Upon Funding
Position End Date
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.
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/
The primary responsibility of the Clinical Research Coordinator B position is to implement study protocols and data collection procedures and to coordinate and support observational studies (both quantitative and qualitative studies). There may also be opportunities to participate in the coordination of Phase I-IV clinical trials. The ideal candidate for this position will have the ability to handle of variety of observational and clinical trial related responsibilities in accordance with the University of Pennsylvania, GCP, ICF, and FDA guidelines. The candidate will participate in study recruitment efforts, writing IRB protocols, and maintaining the regulatory elements of studies. The candidate will also have an opportunity to participate in basic quantitative and qualitative data analysis. The candidate should have excellent communication skills, experience interacting directly with patients in clinical settings, and demonstrate the ability to direct his/her own work with minimal to moderate supervision.DUTIES: The responsibilities of the Clinical Research Coordinator B include but are not limited to: Regulatory: * Draft informed consent forms, data collection forms, protocol revisions and advertisements for regulatory submissions* Prepare components of IRB submissions such as institutional forms, FDA forms, continuing review and modification submissions, deviation and exception memos, and adverse events reporting * Prepare components of all external study site regulatory documentation including Investigator Agreements, FDA forms, CITI trainings, Investigators’ CVs and medical licenses. * Assist senior clinical research staff in communications with study sponsors and to provide proper documentation and enrollment updatesData entry and monitoring: * Basic database creation and management (e.g., REDCap)* Lead development of CRFs for new studies by reviewing and adapting previous study CRFs* Coordinate efforts and feedback between study team and more complex database developers* Review data queries and identify and resolves discrepancies* Assist with data cleaning and data analysis preparation efforts (quantitative and qualitative data)* Work with team to address identified data discrepancies and/or other performance issues* Track and compile completed study visit for sponsor invoicingRecruitment:* Identify and implement strategies to ensure successful patient recruitment and enrollment goals are met within specified timelines including but not limited to development of study brochures, outreach to clinics and private providers, print and radio advertisements and internet advertisement. * Initiate and maintain communications with health care providers and staff at local health care clinics and private practices in an effort to obtain patient referrals* Triage interest inquiries (via telephone, email, or in-person encounters) and prescreen potential participantsEnrollment:* Schedule and coordinate screening/enrollment visits* Perform screening procedures per study protocol including approaching participants in clinic or by phone, requesting and reviewing medical records, and asking eligibility questions* Complete informed consent procedures with patients during standard of care clinic visits as well as during scheduled research encounters * Track recruitment and enrollment progress at Penn and external study sites and prepare weekly updates for the research team* Coordinate communication with research staff at external departments* Recruits, screens and enrolls potential study patients as specified per protocol and implements all study visits and related activities.* Schedules patient visits, coordinating all visit components with multiple departments. * Participates in the necessary financial aspects of patient study participation, including distribution of participant compensation and review of bills for accuracy.Visit implementation/data collection: * Schedule and coordinate all study data collection visits with various Penn clinics/providers and departments for patient baseline, follow up, and end of study visits * Serve as main point of contact for study participants * Collect and record patient demographics, social histories, vitals, concomitant medications, and other relevant data * Work with providers and study participants on the completion of CRFs and source documentation for study assessments, questionnaires, and other data collection procedures* Initiate and complete the required financial procedures and documentation, including proper scheduling of research procedures, for the distribution of participant compensationOther responsibilities:* Support and interact with PIs, co-investigator, research managers, and other CRCs and staff* Prepare components of MOPs, lab manual, and other guidance documentation for new studies * Attends study related meetings * Maintain all relevant trainings and certifications (CITI, GCP, PENN CRC certificate and assigned Penn Profiler trainings) * Adhere to all University of Pennsylvania, GCP, and FDA guidelines* Perform additional duties as assigned which may include assisting with the collection of and handling of human specimens.
The qualifications required for the Senior Research Coordinator position include: * Minimum of a BS/BA and 2-4 years experience in clinical research or an equivalent combination of education and experience. * Knowledge of IRB and Human Research Protection Regulations * Experience working directly with patients* Ability to follow detailed clinical research protocols* Excellent communication and interpersonal skills* Excellent organization skills and demonstrated attention-to-detail* Ability to work independently with minimal to moderate supervision* Ability to multi-task and be flexible in both task and schedule including possibilities of night/weekend work* Proficient with Microsoft Office Suite and electronic database management
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.
Quick Link http://jobs.hr.upenn.edu/postings/35506
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