Elligo Health Research is seeking a highly motivated Research Nurse or Clinical Research Coordinator to join the Clinical Operations group as a Study Manager. These Study Managers will play a key role in assisting 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, ability to prioritize, can-do attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. Elligo is looking for candidates who are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals.
The Study Manager, working closely with study team members under the moderate direction of a Study Director, will have overall responsibilities for coordinating efforts with other study team members in order to achieve study objectives and corporate goals, including:
Develop strong working relationships and maintain effective communication with study team members.
Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets and files), providing timely and quality updates to Elligo management.
Adhere to an IRB approved protocol.
Coordinate protocol related research procedures, study visits, and follow-care.
Maintain study source documents. Report adverse events.
Educate subjects and family on protocol, study intervention, study drug, etc.
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
Collect, process and ship laboratory specimens.
Work directly with prospective and enrolled subjects and their families or caregivers, as applicable.
May promote, advertise, and conduct telephone and face-to-shy; face screenings to recruit potential subjects.
BS/BA in Life Science or related discipline with nursing experience preferred.
Requires a minimum 3 yrs experience coordinating clinical research studies at a healthcare site (including Industry sponsored programs)
Strong interpersonal skills with attention to detail a must. Demonstrated ability in positive relationship building, with strong verbal and written skills required.
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required.
About Elligo Health Research
Elligo helps speed new therapies to market by enabling large numbers of patients and clinicians to participate in clinical research. Studies have shown that only a very small portion of eligible patients participate in clinical research, even though a majority say they are interested in doing so. We remove the logistical obstacles that prevent their participation. Our unique direct to patient model allows us to streamline patient identification and qualification, site activation, patient enrollment, study initiation and study conclusion. This results in more efficient and cost-effective trials and acceleration of new therapies to market. www.elligodirect.com