Clinical Research Coordinator I

About the role

The Clinical Research Coordinator I assists in the conduct of clinical trials by managing study activities, patient scheduling, and data documentation. They serve as the primary point of contact for sites and sponsors while ensuring adherence to protocols and safety regulations.

Responsibilities

• 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.
• Complete all protocol-related training.
• Perform patient/research participant scheduling and collect patient/research participant history.
• Collect and maintain source documentation; perform 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, conduct the informed consent process of research subjects.
• Support the safety of research subjects and 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.
• Follow ethical and professional codes of conduct; adhere to the study plan by ensuring that all approvals are in place and vendors are qualified.
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines and document data according to ALCOA.

Qualifications

• 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.
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office: Outlook, Word, Excel, PowerPoint, 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: 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 agreed-upon timeframes through effective prioritization 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 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 with clinical trial terminology and practices required.
• Ability to manage multiple tasks, evaluate unpredictable scenarios, and achieve project timelines while applying understanding of study protocol(s).
• Strong computer skills, including 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 life-changing treatments for patients.

Education and Experience

• Associates Degree or BS/BA in Life Science or related discipline preferred.
• At least one year of experience in coordinating clinical trials.
• Previous nursing experience in a clinical setting is a plus.
• Prior GCP training and ability to explain the importance of GCP guidelines.

Work Environment

On-site.

Physical Demands

While performing the duties of this job, the employee may: work at a desk using a computer for prolonged periods; regularly communicate via e-mail, telephone, chat, webcam (remote sessions such as MS Teams or Zoom), and exchange accurate and timely information; frequently sit/stand/walk; grasp lightly/fine manipulation of objects; occasionally reach/work above shoulders, twist/bend/stoop/squat, grasp forcefully; lift/carry/push/pull objects that weigh up to 20 pounds.