Clinical Research Coordinator

SUMMARY

The Clinical Research Coordinator I plays a key role assisting 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. This role works closely with study team members and supports other study team members to achieve study objectives and corporate goals.

• Develop strong working relationships and maintain effective communication with study team members.
• Become the point of contact for the site as well as the sponsor for site related activities.
• Manage multiple concurrent trials
• Completes 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
• Support the collection and review of required essential study documents and reports.
• Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.).
• Adhere to an IRB approved protocol
• Once trained, will 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-ups
• 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
• Follows ethical and professional codes of conduct
• 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.

• Ability to identify and explain key protocol elements and perform study tasks Understanding of basic participant safety requirements including safety reports, ICF elements, and role of the IRB
• Strong interpersonal skills with attention to detail are a must
• Demonstrated 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 work with functional groups and different levels of employees throughout Elligo to achieve business results effectively and professionally.
• Proactive and timely follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Clear and concise written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively.
• Strong organizational skills: ability to accomplish multiple tasks within the agreed-upon time frames through effective prioritization of duties and functions in a fast-paced environment.
• Proven track record of building and maintaining solid relationships with both internal and external stakeholders.
• Self-motivated; able to work independently to complete tasks respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.

• Skilled in interacting and working with others, including peers, patients, management, and internal and external stakeholders.
• Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
• Familiarity in clinical trial terminology and practices required
• The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines while being able to apply your understanding of study protocol(s).
• Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS Office products such as Excel and Word.
• An honest and ethical work approach to promote the development of…