Clinical Research Coordinator II - Wellstar Research Institute - FT/Day - Paulding

Wellstar Health System•Dallas, GA

About The Position

The Clinical Research Coordinator II independently manages significant aspects of large clinical trials, registries, and research projects for the WellStar Research Institute. The role develops strategies to recruit and retain research participants and coordinates study activities from participant identification and eligibility assessment through follow-up, data management, and study closeout. The coordinator completes research-related visits and documentation, maintains participant and study records, oversees data management, and trains and guides less experienced staff. The position also participates in IRB submissions, communicates with study sponsors and monitors, reports serious adverse events, resolves study queries, and periodically audits operations for compliance with applicable regulations. It supports research budgets and billing compliance, contributes to quality improvement, and helps ensure the protection of human research participants and the completeness and continuity of study data.

Requirements

At least four years of related research experience is required for candidates with an associate degree.
Associate degree in health science or a related field; bachelor's or master's degree in health science or a related field is preferred.
Basic Life Support certification (BLS, ARC-BLS, BLS-I, or BLS-P) is required upon hire, except BLS-P may be obtained within 30 days.
Knowledge of clinical and translational research operations and their management and implementation.
Advanced knowledge of policies, procedures, and regulations governing human-subjects research, including sponsor contract requirements.
Advanced knowledge of regulations and guidelines for human-subject protection, including FDA, OHRP, GCP/ICH, and HIPAA requirements.
Knowledge of internal research approval processes and the ability to navigate them compliantly, including IRB, grants, contracts, and finance processes.
Ability to conduct multiple studies independently and obtain training or train others to perform or assess protocol procedures safely and accurately.
Ability to collaborate across staff and departments, self-direct, exercise sound judgment, solve problems, and make decisions consistent with Wellstar's philosophy, goals, and objectives.
Ability to build credible internal and external relationships and communicate clearly and concisely verbally and in writing.
Effective presentation and meeting skills.
Strong computer experience, analytical and problem-solving skills, interpersonal and organizational skills, and oral and written communication skills.

Responsibilities

Manage clinical and translational research protocols, including determining eligibility, recruiting and screening participants, scheduling study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking, and other protocol-specific procedures.
Record information from source documentation and participant interactions on paper or electronic case report forms.
Participate in sponsor and regulatory-authority site monitoring visits and data quality assurance reviews.
Receive and track study specimens; package and ship specimens according to sponsor guidelines and applicable regulations, maintaining appropriate documentation.
Complete study closeout activities, including data lock, reporting, archiving study files, and checking data and documentation for completeness and continuity.
Support study budget development and management, clinical trial billing compliance, and reporting to investigators, department administration, and funding agencies.
Observe for adverse events and report them promptly and accurately to the principal investigator and relevant regulatory authorities as required.
Protect human research participants by maintaining communication with investigators, research staff, sponsors, and participants.
Prepare and maintain documents required internally and for regulatory authorities and sponsors before, during, and after clinical or translational trials.
Participate in professional meetings and implement process improvements to support research quality, recruitment, payments, cost savings, and timely reporting.
Define and use performance metrics, share them with investigators and administrators, and track the effectiveness of process improvements.
Network with other research departments and colleagues to share best practices.
Train and instruct others in protocol-specific research procedures.
Participate in training, education, and development activities; pursue continuous learning and maintain required certifications, licensure, and credentials.
Perform other duties as assigned and comply with Wellstar Health System policies, standards of work, and code of conduct.