Clinical Research Coordinator II

Clinical Research Coordinator IIThis 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:Develop 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 trialsAssist with mentoring and training study team membersComplete all protocol-related trainingPerform patient/research participant schedulingCollect patient/research participant historyCollects and maintains source documentationPerforms data entry and query resolutionCollect 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 protocolConduct the informed consent process of research subjects.Support the safety of research subjects, report adverse eventsCoordinate protocol-related research procedures, study visits, and follow-up and anticipate and mitigate potential non-complianceAssist with the screening, recruiting, and enrollment of research subjects.Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activitiesCollect, process, and ship laboratory specimensFollow ethical and professional codes of conduct and escalate noncompliance as neededCommunicate with Stakeholders: CRAs, Project Managers, Patient Services, Account Managers, healthcare practicesAdhere to the study plan by ensuring that all approvals are in place, vendors are qualifiedComply 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.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 tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.RequirementsMinimum 3 years of experience coordinating clinical trials, including the activities listed aboveBS/BA in Life Science or related discipline or equivalent work experiencePrevious nursing experience in a clinical setting a plusCCRC certification a plusDemonstrated ability in positive relationship building, with strong verbal and written skills required.Knowledge of clinical trial terminology and practices requiredDemonstrated ability to coordinate complex protocols with overlapping timelinesPrior GCP training and ability to explain importance of GCP guidelinesManagement of regulatory documents throughout trial lifecycleAbility to train others on key protocol elements and study task executionAble to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements and role of the IRBStrong interpersonal skills with attention to detail a mustFollow ethical and professional codes of conductTake action to minimize participant riskAdhere to the study plan by ensuring that all approvals are in place, vendors are qualifiedComply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and documents data according to ALCOADemonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems.Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.Strong organization/prioritization skills for the management of multiple concurrent projects