Clinical Research Coordinator

Position Description Coordinates daily operations of clinical research studies in assigned department(s). This includes but is not limited to overall clinic conduct, marketing, and data management of all clinical research activities in assigned department(s). Carries out supervisory responsibilities in accordance with policies and applicable laws. Responsibilities may include training new employees; assisting with planning, assigning, and directing work; addressing complaints and resolving problems. The employee is frequently exposed to fumes or airborne particles. The employee is occasionally exposed to toxic or caustic chemicals and dangerous bodily fluids. The noise level in the work environment is usually moderate. Approximately 5-15% travel (often long-distance) is required. Major/Essential Functions Initiates and facilitates study application, regulatory documentation, data collection forms, and additional applicable items for submission and review for ethics committee review and approval (IRB, IBC, IACUC, etc.) or external entity (i.e. UMC) Responds to ethics committee inquiries and stipulations as needed, and submits amendments as needed; this includes preparing and submitting additional modifications for protocols, consent forms, surveys, sponsor monitoring reports and any other attachments or revisions as needed Initiates and completes screening, recruiting, registration and informed consent procedures and associated paperwork for both prospective and current subjects. This includes submitting paperwork in a timely manner and randomization if applicable. In addition, is responsible for determining if a subject is a good candidate for research along with the principal investigator's assessment. Coordinates and schedules subject study visits, procedures, IP reconciliation, required clinical testing, imaging and additional study-specific items and procedures as needed Creates and maintains study regulatory documentation. This includes maintenance of subject data by tracking subjects as they complete protocol-specific study procedures and as data collection is performed Maintains communication with sponsor, principal investigator and ethics committee for any unanticipated events that arise and submits all necessary documentation as needed Assists principal investigator in completion of delegated tasks and helps principal investigator by requesting signatures, reviews, and approvals for both study and subject documentation as needed. Maintains and tracks daily communication with sponsor delegates to ensure site activation and continuous protocol adherence. Completion of tasks includes but is not limited to coordinating and performing a wide variety of research related functions such delegated testing, data collection, data entry, collection and submission of blood/tissue/biological samples. Must be proactive and timely in all areas of trials, and must provide principal investigator with consistent updates Monitors and reviews all study-related documentation to ensure that it is complete and correct. In addition, ensures that all clinical research studies are compliant with Federal and institutional regulations Participates in data query resolution with sponsored studies Facilitates communications and meetings with study sponsors and monitors. Manages, updates and maintains additional documentation associated with research team training, CVs, financial disclosures, subject payment information and Swift card requests, etc. Adhere to all policies, procedures and practices (Regents Rules, TTUS, HSECEP OPs, etc.) Personally demonstrate, display and act in accordance with TTUHSC EP's Values (Service, Respect, Accountability,Integrity, Advancement, and Teamwork). Serve as a Value's leader while actively promoting and encouraging staff across the institution Remains current with all licensure, certifications and mandatory compliances and trainings required of this position Perform all other duties as assigned Preferred Qualifications Demonstrated experience in clinical trials and coordination of research grants Knowledge and proficient in

Microsoft:

Word, Outlook, Excel, PowerPoint, Access, working knowledge of SPSS Bilingual Spanish/English Experience working with IRB and strong understanding of regulatory requirements Knowledge of the implementation, coordination or management of clinical research programs Ability to build and maintain effective working relationships with individuals at all organizational levels and with the general public. Strong problem-solving skills, with the ability to manage multiple variables in standardized situations. Sound judgment and the ability to work effectively under pressure and meet established deadlines. Understanding of TTUHSC's mission, vision, and goals, and the role of the Clinical Research Coordinator in supporting them. High level of accuracy and proficiency in the use of personal computers and assigned software applications. Detail-oriented with strong organizational skills. Pay Statement Compensation is commensurate upon the qualifications of the individual selected and budgetary guidelines of the hiring department, as well as the institutional pay plan. For additional information, please reference the institutional pay plan website. EEO Statement All qualified applicants will be considered for employment without regard to sex, race, color, national origin, religion, age, disability, protected veteran status, or genetic information. Required Qualifications Healthcare related training with current licensure/certification in their field OR Bachelor's degree from an accredited university with a major in the area of research being conducted

Certification:

Certified Clinical Research Professional as defined by The Society of Clinical Research Associates or Certified Clinical Research Coordinator as defined by the Association of Clinical Research Professionals OR Ability to obtain certification as a Clinical Research Professional/Coordinator within two years from date of hire or upon eligibility. Jeanne Clery Act The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act is a federal statute requiring colleges and universities participating in federal financial aid programs to maintain and disclose campus crime statistics and security information. By October 1 of each year, institutions must publish and distribute their Annual Campus Security Policy & Crime Statistics Report (ASR) to current and prospective students and employees. You can locate this report through our website at: https://www.ttuhsc.edu/emergency/clery-report.aspx