Overview

The Clinical Research Coordinator II independently manages significant and key aspects of large clinical trials, registries and research projects for the WellStar Research Institute of the WellStar Health System. This includes determining effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. 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. The incumbent will train and provide guidance to less experienced staff. 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.

Responsibilities

Core Responsibilites and Essential Functions

Clinical & Translational Trial Management
* 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.

Regulatory & Compliance
* 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.

Research Advancement
* Participates at professional meetings
* Assesses for and implements process improvement initiatives within a clinical/translational trial to assure research quality, and expedient completion of recruitment, timely receipt of research related payments and cost savings and expedient study reporting
* Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes
* Networks with other research departments and colleagues to share best practices

Training & Education
* 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.
* Participates in and maintains certifications, licensure and credentialing as required by Wellstar Health System and/or sponsors

Required for All Jobs

Performs other duties as assigned

Complies with all WellStar Health System policies, standards of work, and code of conduct.

Qualifications

Required Minimum Education

Associate's Degree in a related life science or healthcare field Required and

Bachelor's Degree in a related life science or healthcare field Preferred or

Master's Degree in a related life science or healthcare field Preferred

Required Minimum Experience

Minimum 4 years related research experience required for an Associate?s Degree. Required

Required Minimum Skills

Knowledge and understanding of the management and implementation of clinical/translational research operations.

Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research.

Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations.

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 conduct multiple studies independently, obtain training or train others to safely and accurately perform or assess required protocol procedures.

Works collaboratively with other staff and departments to complete research protocols.

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.

Excellent interpersonal and organizational skills, good oral and written communication skills.

Required Minimum License(s) and Certification(s)

ACRP-CP, CRC, CRA or CCRP Required

Additional Licenses and Certifications