Sr Clinical Research Associate
Sr Clinical Research Associate
Dept Number/Name: 0-6125-000 / Dept of Neurology
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 annual
Position Number: 00050041
Neurology has entered the forefront of this exciting era by strategically aligning a wealth of resources in the basic and clinical neurosciences throughout the University, in partnership with the novel USF Neuroscience Collaborative. The neurology department continues to grow and maintain the largest clinical research portfolio in the MCOM.
USF Neurology also offers optimal training and education to our medical students, residents, fellows, practicing physicians and the community. Our residency program is large and robust, with excellent clinical training and patient resources across the full spectrum of Neurology, as well as a rich and detailed didactic curriculum over the three years of training, including a guaranteed first year of general internship for entering residents. We offer all of this in the beautiful urban center and coastal resort community of Tampa, Florida.
This position will be working in the Ataxia Division in the Neurology Department working on coordination and management of all regulatory requirements for ongoing research including initial approvals, amendments, continuing reviews, and reportable events. Will facilitate training of clinical research staff as required per protocol. Coordinates complex clinical trial protocol requirements and assists all staff with troubleshooting to avoid protocol deviations.
This position will serve as liaison for the division in different situations including with sponsors, vendors, other external departments and collaborators. Will work to refine and adapt policies and procedures as necessary. Duties also include: Start up, close out, continuing reviews, budgets, working with OCR Department.
Completion and maintenance of all regulatory documentation (startup packets, training, logs, amendments and continuing reviews). Tracking of divisional staff changes, protocol amendments and deviations. Work with regulatory agencies such as the FDA and institutional review boards for study approvals.
Develop and interpret policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP). Review accumulating data and communicate with study coordinators regarding data quality and data completeness. Monitor data compliance by clinical sites, reporting findings to the study investigator. Ensure quality of study data through identification, evaluation and resolution of discrepancies and other efforts to reduce data errors by researchers. Coordination of staff across multiple studies, including coordination with various departments, patients, locations. Working within various systems to capture all data (electronic databases, patient records, patient payments and status logs).
Oversee and assist in protocol development and electronic case report form (eCRF) design; obtain and maintain regulatory compliance approval for the all active research. Develop SOP documents: review medical protocol and prepare draft of document; coordinate with protocol Principal Investigator preparation of final document for research staff training. Track changes in protocol requirements and form definitions.
Recruits patients from the PI's clinic, though support groups or through online recruitment site. Identifies patients in existing patient database though chart/records review sites. Collects data from research subjects at patient's visits. Processes and analyzes subject prior to shipping to central laboratory.
Training of new site staff,- ongoing trainings (amendments), documentation of training. Act as resource for all staff, assist with other projects as needed (fiscal).
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.
At least 4 years of experience in a research setting and 2 years of experience in clinical trials. At least 2 years of administrative and management experience.
Information for Applicants
This position is subject to a Level 1 criminal background check.
Posting Date: 07/27/2022
Posting End Date: 08/03/2022
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.
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 & 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. USF is a member of the American Athletic Conference.
Working at USF
With more than 16,000 employees at USF, the University of South Florida is one of the largest employers in the Tampa Bay region. At USF you will find opportunities to excel in a rich academic environment that fosters the development and advancement of our employees. We believe in creating a talented, engaged and driven workforce through on-going development and career opportunities. We also offer a first class benefit package that includes medical, dental and life insurance plans, retirement plan options, tuition program and generous leave programs and more.
To learn more about working at USF please visit: Work Here. Learn Here. Grow Here.