Sr Clinical Research Associate

Position Details Dept Number/Name: 0-6123-000 / Dept Of Internal Medicine College Division: USF Health-Morsani College of Medicine Salary Plan: Administrative (Grant-Funded) Job Code/Title: 4435 / Sr Clinical Research Associate Hiring Salary/Salary Range: $72,000-$80,000 Position Number: 00049025, 00049026 Authorized to work in the US is a prerequisite for this position and we are unable to sponsor work visas for this position. ORGANIZATIONAL SUMMARY: The Department of Internal Medicine is the largest and most complex Department in the Morsani College of Medicine with over 26 Divisions, Programs and Centers/Institutes, total human resources in excess of 1,000, and an annual all-source budget in excess of $143,000,000. The Department's ongoing growth includes the restructure of Cardiovascular Sciences from a separate Department to a Division, support of the microbiome initiative, and the execution of clinical, research and education initiatives focused on COVID-19 and emerging infectious diseases.

The mission of the Department is to rank among the elite in the nation in the areas of education, research and patient care. The Department provides education and training for a diverse group of medical students, residents, fellows and health personnel from USF and throughout the world. The Department's research activities are numerous and involve both basic and Clinical Research activities in all subspecialties of Internal Medicine.

Our National Institutes of Health (NIH) funding is in excess of $120 million over the past 3 years. Patient care occurs in our affiliated hospitals (including Tampa General Hospital, H Lee Moffitt Cancer Center and Research Institute, James A Haley VA Hospital, Florida Hospital) as well as our state-of-the-art ambulatory health care centers. The Department also provides healthcare support and services via contractual arrangements with many diverse organizations.

The US News & World Report recent rankings of our subspecialties include Nephrology at 18, and Gastroenterology at 24 and Primary Care at 67. The Department's faculty represent a group of dedicated physicians that are well-recognized as leaders in all three mission areas. POSITION SUMMARY: The Sr.

Clinical Research Associate plans, organizes, and manages the resources necessary to achieve Clinical Research project goals and objectives. The primary purpose of the position is to ensure that all clinical trials are conducted in accordance with study protocols, FDA regulations and ICH/GCP guidelines by way of internal audits, oversight/guidance and training for site locations. This position is grant funded.

RESPONSIBILITIES: Track Clinical Research training for all clinical study coordinators in the defined unit. Oversight and overall management of coordinators. Train on patient recruitment, screening and other research related services, interventions, and evaluations per protocol for participants enrolled in Clinical Research studies.

Collect, process and ship research specimens. Achieve and maintain certification in biohazardous materials shipping. Educate patients, and families.

Coordinate, prepare and participate in monitoring visits. Coordinate and serve as project lead for special projects and initiatives for the overall good of the project and/or grant. Responsible to coordinate, conduct, evaluate research related activity for Clinical Research projects as assigned.

Oversees screening, enrollment, and retention of study participants, coordinates study visits, ensures quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator. Provide guidance on day to day operations of the Department of Internal Medicine Clinical Research operations to all users of this shared resource. Develop source documents and validation studies to be in compliance with Good Clinical Practice.

Provide input to Clinical Research operations to ensure compliance to SOPs and other relevant Good Clinical Practice (GCP) requirements. Prepare and submit documents for the Institutional Review Board(s), and other research review boards and committees as applicable according to regulatory and institutional requirements. Compile and maintain regulatory files for assigned protocols.

Coordinate, prepare for and participate in monitoring visits, audits and inspections. Track and maintain reporting (i.e., PI/Division activities, pending/enrolling/closeout of studies) for the defined unit for mid-year and annual executive summaries, research reporting to the Department Chair, Vice Chair(s), Division Directors and Chief Administrative Officer(s). Performs other duties as assigned.

POSITION QUALIFICATIONS: MINIMUM: This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience. PREFERRED: Bilingual - Spanish. Certified in Clinical Research with a reputable Clinical Research society.

Master's degree in Biological Science, Public Health, Health Science, Nursing or other directly related field. RN, State of FL. Phlebotomy trained.

Experience in REDCAP, EPIC, eBinder software (FLORENCE) or data management/Clinical Research tracking software. Prior management experience preferred. SPECIAL SKILLS/TRAINING: Ability to work independently and in a group setting.

Creative problem solver, ability to manage tight deadline, impeccable time management, and excellent verbal and written communication. USF Health Information for Applicants This position is subject to a Level 1 criminal background check. Authorized to work in the US is a prerequisite for this position and we are unable to sponsor work visas for this position.

Job Opening Number: 35021 Posting Date: 09/06/2023 Reposting Date: 01/01/2024 How To Apply Click on the Apply Now button. When applying to an opening you will have the opportunity to upload a cover letter and resume. Apply online by completing the required information and attaching your cover letter and resume.

Please include your experience as it relates to the qualifications stated above. YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.

Click here for additional tutorial information. Equal Employment Opportunity USF is an equal opportunity, equal access academic institution that embraces diversity in the workplace.The University of South Florida does not discriminate on the basis of sex and prohibits sexual harassment. Any person may report sex discrimination, including sexual harassment (whether or not the person reporting is the person alleged to be the victim of conduct that could constitute sex discrimination or sexual harassment), in person, by mail, by telephone, or by electronic mail, using the contact information listed for the Title IX Coordinator.

Reports may be made at any time either online or directly to the University's Title IX Coordinator. Work Location Campus map and location overview: USF - Health USF - Tampa Campus About USF The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S.

News and World Report's national university rankings than USF. Serving more than 50,000 students on campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF is designated as a Preeminent State Research University by the Florida Board of Governors, placing it in the most elite category among the state's 12 public universities.

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