CLINICAL TRIALS SPECIALIST

Location
Durham, NC
Posted
May 03, 2017
Institution Type
Four-Year Institution

CLINICAL TRIALS SPECIALIST
DCRI - Imaging Program

Occupational Summary Coordinate and participate in a variety of specialized technical activities involving the collection, preparation, and analysis of digital ECG data, performing a variety of research and database activities to support multi-center clinical trials involving Phase I, II, II, FIM, feasibility, pivotal and DIVA clinical research trials for the eECG Core Laboratory and cardiac safety #for profit# business unit. Provide resources and mentoring to new staff and trial cardiologists. Work Performed Follow SOPs and regulatory guidelines in the collection of clinical data and the administration of clinical trials. Function as an expert user on the unique ECG analysis platforms/portals used for the collection of static and continuous digital ECGs for arrhythmia, efficacy, safety, cardiac mapping and DIVA studies. Perform complex arrhythmia analysis, primary ST labeling for ST resolution studies, detailed interval assessment, and provide the initial diagnosis and interpretation of critical alerts on static ECGs to support protocol requirements. Provide and participate in the ongoing training/mentoring of CTAII, CTAI and trial cardiologists to support project related analysis; orient new staff and monitor quality control SOP requirements for operational staff related to inter and intra reader variabilities. Participate in the identification and evaluation of new technologies and ECG platforms. Participate with IT QA in the preparation of the validation plan and validation process on new and retro system validations. Perform multi-task work duties successfully on a daily basis and consistently meeting identified timelines. Demonstrate competency in the following CTA II skills and perform as needed: Maintain logs of clinical trials; record shipping forms received and file as appropriate; prepare reports from logs, includingweekly data reports, monthly invoicing reports and others as requested by project leader. Receive, process and perform QA on Echo VHS/MOD/CD data, static ECGs, and continuous ECG data submitted on flash memory cards and received via File Transfer Protocol (FTP). Perform initial data entry of header information into EDC eCRF. Prepare continuous 12 lead files for primary and physician overread, and perform initial annotation of cardiac safety ECGs using a variety of ECG platforms and web portals. Coordinate the transfer, parsing and problem resolution of physician overread ECG files into EDC system. Assist CTC and Statistician in resolution of EDC generated queries and preparation of soft and hard lock prior to interim and final transfer of data. Assist in maintaining communication with sites and PIs to provide information concerning continuous ECG quality and to track documentation of received ECG data; ensure that study materials are shipped and re-supplied as requested. Document all communication with sites. Attend weekly core lab meetings and project related meetings as directed by project leader. Communicate with team members to share information as necessary and with other study personnel concerning data progress and routine problem resolution. Prepare a variety of reports for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trial#s progress. Maintain by project, inventory of monitoring equipment, flashcards, and disposable supplies. Provide on-call technical support for multi-center studies and demonstrating knowledge of protocol in order to respond tosite questions or triage calls as appropriate. Participate in investigator meeting, on site training, and site certification for US and OUS sites. Required Qualifications: 1. Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or 2. Completion of a bachelor's degree plus a minimum of two years closely related research experience; or 3. Completion of an associate's degree plus four years of experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information. Experience: None required beyond that described above.

Requisition Number
401230520

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
70 CLINICAL TRIALS SPECIALIST

Job Family Level
10

Exempt/Non-Exempt
Non-exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

1. Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or 2. Completion of a bachelor's degree plus a minimum of two years closely related research experience; or 3. Completion of an associate's degree plus four years experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information.

Experience

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

87279BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI97689322