Clinical Research Coordinator I

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.

ESSENTIAL DUTIES

• 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.

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 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 timeframes 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.

CRC Qualifications

• 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 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

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.

ADDITIONAL:

Elligo Health Research is a dynamic organization in a rapidly changing industry. Accordingly, the responsibilities associated with this job may change from time to time in accordance with business needs. More specifically, the incumbent may be required to perform additional and/or different responsibilities from those set forth above.

The above declarations are not intended to be an all-inclusive list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are designed only to describe the general nature of the job.

The incumbent must be flexible as there may be workweeks that require more than 40 hours to ensure the positions expectations and responsibilities are met.

Elligo Health Research is committed to a policy of equal employment and will not discriminate against an applicant or associate based on his or her age, sex, sexual orientation, gender identity, race, color, creed, religion, national origin or ancestry, citizenship, marital status, familial status, physical or mental disability, handicap, military or veteran status, genetic information, pregnancy or any other category protected under federal, state or local law, regulation or ordinance.