Clinical Research Operations Manager

Arrow Clinical Trials is a leading clinical research site dedicated to advancing medical science through innovative clinical trials. We partner with pharmaceutical, biotechnology, and medical device companies to bring promising treatments to patients faster. We are seeking an experienced full-time Clinical Research Operations Manager to oversee our Daytona Beach clinical research site. Candidates should be an established health care professional with a Experience in Clinical research. The manager will be responsible for overseeing the daily clinical operations, implementation and conduct of multiple clinical trials and ensuring all research activities are coordinated in compliance with federal, state and local regulations. Excellent verbal and written communication skills and an ability to communicate with a diverse group of people in a clear and concise manner. Detail oriented and highly organized. Self-motivated with the ability to work effectively while managing multiple studies and projects. Promote a team approach with high standards of professionalism and productivity. Expected routine responsibilities:

• Manages all clinical and operational aspects of the research office in accordance with GCP guidelines and all federal, state and local regulations. Exhibits strong study management skills through organization, communication, problem solving, conflict resolution and leadership.
• Provides direct oversight of the research staff and conducts annual performance reviews. while ensuring all training for staff is up-to-date
• Sustains frequent communication with the physicians and leadership while leading office meetings, as well as being available for further discussion as necessary.
• Functions as point of contact related to clinical operations for new or ongoing trials. As such, completes feasibility questionnaires, helps with regulatory documents and assists in the execution of study start-up activities.
• Maintains a quality assurance program by conducting internal reviews and implementing corrective actions as necessary. Meets with Sponsor/CRO designees to discuss study performance and mitigating any staff issues.
• Performs all essential duties of the Clinical Research Coordinator.
• Creates and/or maintains documents and records related to the study
• Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress
• Manages the inventory of equipment and supplies related to the study and orders more as needed
• Collects specimens and inputs data and patient information into electronic systems
• Creates reports on each study, including notes on protocols, workload, data collection, and more
• Excellent written and verbal communication skills
• Superior organizational and time management skills
• Capable of working independently with minimal supervision and as part of a team
• Skilled with standard computer programs including the MS Office suite
• Understanding of medical terminology as well as standard clinical procedures and protocols
• Prior experience training and mentoring staff members is preferred

Qualifications:· Bachelor’s degree in Life Sciences, Nursing, or related field (or equivalent experience).· Experience in Leadership role (Clinical Research Coordinator, Clinical Research Manager, or similar).· Strong understanding of GCP, ICH guidelines, and regulatory requirements.· Proven experience in managing clinical trials, staffing, and timelines.· Excellent communication, organizational, and problem-solving skills.· Clinical research certifications (e.g., CCRA, CCRC) preferred but not required.

Job Type: Full-time

Pay: $80,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

People with a criminal record are encouraged to apply

Ability to Commute:

• Daytona Beach, FL 32117 (Required)

Ability to Relocate:

• Daytona Beach, FL 32117: Relocate before starting work (Required)

Work Location: In person

Salary : $80,000 - $115,000