Job Description

SUMMARY :

Oversees, coordinates, develops, and manages the day-to-day clinical activities for specified research trials in accordance with the research parameters established by the Principal Investigator (PI). The Clinical Research Coordinator I (CRC I) promote good clinical practices in the conduct of investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection. The CRC I conducts clinical tasks per protocol and as delegated by the PI and sponsoring organizations. The CRC I assures compliance with protocol and regulatory requirements by collecting, recording, and maintaining data and source documentation. The CRC I will work closely with the PI's, department members, study sponsors, and the institution, to support administration of the compliance, invoicing, personnel, and other related aspects of all ongoing clinical studies.

CRC I is an entry-level position responsible for serving as the primary coordinator for post-market, phase 3, and pivotal studies - and serving as the backup coordinator for all other phase studies. Supports both inpatient and outpatient research across all age groups and indications.

ESSENTIAL FUNCTIONS :

Facilitate and coordinate daily clinical activities; play a critical role in the conduct of all studies. Act as liaison between PI's, ancillary departments, research subjects, sponsoring organizations and regulating bodies, vendors, brokers, and suppliers of products and services.

Maintain regulatory documentation, including the Investigator Site File (ISF).

Prepare, submit, and track Institutional Review Board (IRB) submissions, amendments, and reports; ensure ongoing compliance with regulatory requirements and timely IRB reporting.

Ensure investigational product (IP) accountability throughout the study.

Coordinate study and Research Staff compliance metrics.

Coordinate participant recruitment and outreach programs.

Coordinate department quality and data integrity programs.

Support research billing compliance and invoicing/financial administration as required.

Conduct interviews, schedule participant appointments, administer surveys for research purposes, collect and aggregate data, and act as patient liaison for the PI.

Serve as a member of the research team.

Maintain required documentation including source documentation, subject logs, various records, reports, and other essential documents.

Perform data mining and data entry.

Develop contingency plans and respond to unforeseen circumstances utilizing planned resources.

Serve as program liaison between the department and research partners.

Order and maintain study supplies.

Adhere to TMCH organizational and department-specific safety, confidentiality, values, policies, and standards.

Perform related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION: Bachelor's degree in a relevant field or equivalent experience.

EXPEREINCE: None required. One (1) year of relevant experience preferred.

LICENSURE OR CERTIFICATION : Good Clinical Practice, Human Research Protection Training, and Basic Life Support certifications required within 30 days of start date. ACRP/SOCRA certification preferred.

KNOWLEDGE, SKILLS, AND ABILITIES :

• Ability to understand clinical research theory, practices, and tools utilized (preferably within the hospital or healthcare industry).
• Above-average skill in the use of all Microsoft Office applications (e.g., Excel, PowerPoint); familiarity with spreadsheets and statistical data is necessary for quality improvement and tracking projects.
• Proficient with technology and comfortable learning new protocols, electronic data capture (EDC) systems, and electronic medical records (EMRs); able to adapt to multiple EMR platforms and EDCs as required by different studies.
• Knowledge of clinical care and assessment best practices as well as related clinical components.
• Knowledge of regulations and policies as they relate to patient research, evaluation, care, and information.
• Ability to maintain investigational product accountability and comply with study drug/device handling requirements.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations.
• Highly organized and able to multi-task.
• Ability to write reports, correspondence, and procedure protocols.
• Ability to effectively present information and respond to inquiries or complaints from patients and/or their representatives, and the general public.
• Ability to work with concepts such as fractions, percentages, ratios, and proportions, and to apply mathematical operations to solve or analyze job-related situations.
• Ability to identify positive or negative variances from expected outcomes.
• Requires problem solving, decision-making, critical thinking, analytical, and deduction skills.
• Ability to work with diverse populations and adjust approaches as needed; demonstrated compassion, integrity, and ability to work with a wide range of disciplines.
• Ability to be sympathetic, culturally sensitive, and emotionally supportive to the patient/family throughout the care continuum.
• Must maintain a positive and professional attitude through stressful situations.
• Must be able to work in a self-directed environment, with an ability to work with teams.
• Excellent presentation skills: ability to implement professional and community-based education programs.

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