Coor Clinical Research I

Wellstar Health System • Marietta, GA

1d • Onsite

About The Position

The Clinical Research Coordinator I independently manages key aspects of clinical trials, registries and research projects for the WellStar Research Institute of the WellStar Health System. Responsibilities include identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating research-related visits; completing and filing necessary forms with internal and external departments and agencies as necessary; maintaining records for patients enrolled in clinical trials; and overseeing data management for research projects. This position also participates in IRB submissions and responds to requests and questions effectively, interfaces with study sponsors, monitors, and reports SAEs; resolves study queries and periodically audits operations to ensure compliance with applicable regulations.

Requirements

• Associate's Degree in a related life science or healthcare field.
• Bachelor's Degree in a related life science or healthcare field.
• All certifications are required upon hire unless otherwise stated.
• Minimum 2 years research experience required for an Associates Degree
• No related research experience required for a Bachelors Degree.
• Knowledge and understanding of the management and implementation of clinical/translational research operations, policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research.
• Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects.
• Knowledge of the policies and procedures and requirements of internal departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and assure compliance throughout the research process.
• Able to obtain training or train others to safely and accurately perform or assess required protocol procedures.
• Ability to self-direct, exercise appropriate judgment, problem solve and make decisions consistent with WellStar philosophy, goals and objectives.
• Ability to build credible relationships internally and externally.
• Possesses ability to communicate, both verbally and in writing, clearly and concisely.
• Uses effective presentation and meeting techniques.
• Strong computer experience necessary.
• Strong analytical and problem-solving skills.

Responsibilities

• Utilizes coordination skills to complete all research protocols, including patient eligibility determination, recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures
• Records data from source documentation and/or participant interaction onto case report forms
• Participates in periodic site monitoring visits from sponsor, regulatory authorities, and others. Participates in data quality assurance reviews.
• Receives and tracks receipt and status of study specimens from multiple sites. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
• Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation
• Supports the development and management of study budgets, supports the maintenance of clinical trial billing compliance and provides reports to investigators, department administration and funding agencies.
• Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
• Serves as an advocate for human subjects by establishing and maintaining communication with investigators, research staff, sponsors and participants to ensure protection for human participants of research
• Prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.
• Participates at professional meetings
• Networks with other research departments and colleagues to share best practices
• Trains and instructs others in performing procedures for research as described in the protocol
• Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities.
• Performs other duties as assigned
• Complies with all Wellstar Health System policies, standards of work, and code of conduct.

Benefits

• Join us and discover the support to do more meaningful work—and enjoy a more rewarding life.
• Connect with the most integrated health system in Georgia, and start a future that gives you more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree