Schedule:

Full time

Shift:

Day (United States of America)

Address:

601 E ALTAMONTE DR

City:

ALTAMONTE SPRINGS

State:

Florida

Postal Code:

32701

Job Description:

Develops and implements standard operating procedures (SOPs) and work instructions for clinical trial processes. Trains, mentors, and develops clinical research staff to ensure high-quality performance. Collaborates with managers and leaders to facilitate the initiation and completion of clinical research studies. Supervises day-to-day activities of the clinical research team, ensuring efficient workflow and productivity. Monitors and evaluates the quality of data operations, reviewing monitor follow-up visit letters and sponsor reports. Provides oversight on action items requiring follow-up to ensure timely resolution. Other duties as assigned. Builds and maintains supportive relationships with team members through regular communication and feedback. Ensures accurate and timely data entry and management in clinical trial databases. Conducts regular audits and quality checks to ensure data integrity and compliance. Coordinates with external partners and stakeholders to ensure smooth trial operations. Prepares and submits required documentation and reports to regulatory authorities and sponsors. Manages the overall conduct of clinical trials to ensure compliance with trial protocols, FDA regulations, and ICH/GCP guidelines. Knowledge, Skills, and Abilities:
• Possesses the ability to supervise clinical research teams, lead and accept responsibility, exercise authority, and function independently using effective written and verbal communication in English. [Required]• Ability to train and mentor Clinical Research Data Coordinators and Research Support Assistants. RequiredKnowledge of applicable Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS), and National Institutes of Health (NIH) governing the conduct of clinical research.[Required]• Specialized knowledge of the unique needs of volunteers participating in clinical trials. [Required]• Demonstrated ability to identify improvement opportunities in a clinical research setting. [Required]• Proficiency with coordination of multiple clinical trials, while providing supervisory support to the team. [Required]• Demonstrated ability to keep a positive attitude and critically think in a fast-paced environment, with an analytical approach to problem-solving. [Required]• Sensitivity to cost-containment measures and ability to create an atmosphere which encourages this practice. [Required]• Proficient with a Clinical Trials Management System (CTMS). [Required]• Proficiency in Microsoft Office applications (i.e., Outlook, Word, Excel, Teams, etc.) and the ability to learn business-relevant software and tools. [Required]• Interpersonal communication skills: ability to interact and maintain good relationships under all circumstances with employees, a broad spectrum of healthcare disciplines, and the public. [Required]• Expert knowledge of clinical research and research regulatory environment. [Required]• Acclimate and integrate into various clinical specialties as needed per study protocol. [Preferred]
Education:
• Associate [Required]• Bachelor's [Preferred]
Field of Study:
• in Healthcare Administration, Research, or related field and at least 2 years of experience in clinical research
• in Healthcare Administration, Research, or related field

Work Experience:
• 3+ of experience in clinical research or related field. [Required]
Additional Information:
• N/A

Licenses and Certifications:
• Certified Clinical Research Coordinator (CCRC) [Preferred]• Certified Clinical Research Professional (SOCRA) (CCRP) [Preferred]• Certified Clinical Data Manager (CCDM) [Preferred]
Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/msy4mja2

Pay Range:

$59,652.52 - $110,956.61