Become A Clinical Research Assistant

* Assists with the daily operational needs of one or more training and research grants.
* Actively works with principal investigator(s) to recruit patients for assigned studies.
* Distributes marketing materials, schedules, and screens potential study participants and ensures participant confidentiality is maintained.
* Confers with study participants to explain purpose of study and obtain informed consent.
* Coordinates collection and mailing of biological samples for laboratory analysis in compliance with research standards and protocols.
* Administers basic psychophysiological assessments under the direction of the PI.
* Manages study databases and assists with data entry and analysis.
* Ensures accuracy of data obtained and reported.
* Assists PI(s) in completing IRB paperwork
* Maintains records to demonstrate compliance with grants and assists PD/PI to draft reports for federal agencies.
* Manages the study “lab” equipment and supplies to ensure appropriate supplies and assessments are available and equipment is in working order.
* May conducts literature reviews on assigned topics and prepares synthesis of findings in a report.
* Assists with administering informed consent to research subjects and data collection both onsite and offsite.
* Provides general clerical support to research staff

* Assists with obtaining and preparing regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms.
* Under close supervision, ensures documents and forms are compiled and submitted in a timely manner to the CRO, study sponsor or IRB as applicable.
* Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study.
* Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study.
* Under close supervision, interfaces with potential study subjects for the purpose of promoting participation in research studies.
* Assists with the screening of subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI.
* Assists with and documents the obtaining of informed consent according to GCP.
* Assists with the timely and accurate data entry of study specific data into case report forms.
* Assists with addressing and resolving study sponsor questions, concerns, and queries in accordance with timelines established by the study sponsor.
* Processes and ships study specific lab specimens as directed by the PI.
* Performs study specific procedures at protocol directed intervals under the supervision of the PI.
* Provides general support for research projects as directed by the PI, Director, or other site personnel.
* Obtains and updates essential documents for specific studies, as necessary.
* Attends clinical research-related training as required.
* Assists with study close-out activities as directed by PI.
* Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner.
* Escalates issues to supervisor for resolution, as deemed necessary.
* Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and
* federal laws and regulations.
* Assists with various projects as assigned by direct supervisor.
* Other duties as assigned

* Perform data abstraction from medical records; data entry, data updating, tracking and querying for bio-specimen project general database ensuring consistency of data collected, protocol adherence and data quality.
* Maintain subject databases which include subject registration in melanoma bio-specimen database and Abramson Cancer Center research subject registration database
* Track patients’ treatment and clinical trial participation status and follow-up visits; assist with participant recruitment, such as patient screening and consenting
* Prepare blood collection kit, coordinate blood sample collection and transfer to relevant laboratories
* Perform general administrative duties such as updating study calendars, ordering supplies, filing and scheduling melanoma clinical research meetings
* Other duties and responsibilities as assigned, serve as melanoma tumor board coordinator
* Position contingent upon funding

* Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols.
* May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol.
* Checks all eligibility and ineligibility criteria with the research subjects' medical record.
* Verifies information with clinical research nurse and/or principal investigator.
* Discusses informed consent with research subjects.
* Interacts with research subjects prior to entering the study and throughout the entire treatment.
* Assists with scheduling appointments and follow up tests.
* Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects.
* Reviews protocol requirements with physicians, nurses and fellows.
* Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse.
* Begins to learn how to independently resolve problems with protocol.
* Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols.
* Enters data into computerized system

* Apply clinical skills requiring a nursing license to deliver and evaluate research protocols and clinical trials in Cardiothoracic Surgery.
* To participate in the design, execution, and control of cardiothoracic clinical research trials; coordinate the processing and analysis of trials data; coordinate clinical trial protocols and procedures; develop new and/or revised research methodologies; provide supervision of protocol staff
* Characteristic Duties and Responsibilities:Assist in the design, development, execution and administration of protocol and clinical studies
* Participate in the development of the general research goals and in the planning of the implementation of the clinical trials
* Prepares IRB submissions according to University guidelines
* Maintains grants' regulatory files according to granting agency and University policies
* Oversee operations of clinical research studies including the recruitment, coordination and scheduling of subject participation and procedures per protocol requirements.
* Assist physicians in determining eligibility of patients for research protocols
* Perform physical exams and follow-up visits including expanded nursing procedures, as well as, reviewing medical histories, test results and symptoms to determine eligibility or need for treatment, follow-up, and/or referral per research protocols
* Enrolls patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters
* Organize clinic/study procedures, follow study participants and manage collection of accurate data in a timely manner, keeping data and documentation secure and confidential
* Assist and/or direct others in obtaining patient consent to enter protocols and counsel patients and families regarding investigational therapy
* Coordinate services/referrals as appropriate with other departments participating in the clinical research as appropriate
* Coordinate patient care needs and obtain follow-up information from local physicians or laboratories or appropriate healthcare providers per established research protocols
* Serve as a liaison to local physicians/hospitals and collaborating institutions to facilitate care of protocol patients
* Assist patients with problems related to their protocol therapy such as consultation when calling concerns related to: returning for emergency evaluation in the case of side effects, assisting with emotional problems or other related issues
* Maintain records of services provided and work within individual protocol budgets
* Serve as a liaison to the University Business Office to identify exact patient tests and procedures which are paid for by study sponsors, and to assist with questions related to billing for protocol treatment procedures
* Perform critical analysis of literature relevant to the clinical trials
* Assist in judging validity of data and make recommendations.
* Perform complex statistical analysis of data and prepare data for computer analysis.
* Use evaluation data to revise and implement change
* Assist in the preparation of research papers and manuscripts for publication and presentation at conferences and workshops, and in the writing of project reports, articles and other documents for submission to study sponsors
* Supervise protocol research support staff