Clinical Research Coordinator II

All Jobs  >  Clinical Research Coordinator II Apply Clinical Research Coordinator II Austin, TX Apply Description JOB SUMMARY(To perform this job satisfactorily, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.) This individual will play a key role in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, the ability to prioritize, a “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team-building skills.  The CRC II will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals, including: ESSENTIAL DUTIESDevelop strong working relationships and maintain effective communication with study team members.  Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials  Assist with mentoring and training study team members  Complete all protocol-related training  Perform patient/research participant scheduling  Collect patient/research participant history  Collects and maintains source documentation  Performs data entry and query resolution  Collect and review required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.).  Adhere to an IRB-approved protocol  Conduct the informed consent process of research subjects.  Support the safety of research subjects, report adverse events  Coordinate protocol-related research procedures, study visits, and follow-up and anticipate and mitigate potential non-compliance Assist with the screening, recruiting, and enrollment of research subjects.  Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities  Collect, process, and ship laboratory specimens  Follow ethical and professional codes of conduct and escalate noncompliance as needed Communicate with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, healthcare practices Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified  Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents data according to ALCOA. Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), and guidelines. WORKING CONDITIONSThe above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Traveling CRC II positions will require (50%) travel for this position. Non-traveling will require (15- 25%) travel. Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not...