Clinical Research Coordinator

ce. The work we do building families offers stimulation, challenge, and personal reward.

The Clinical Research Coordinator works under the immediate direction and supervision of the principal investigator and collaboratively with the Clinical Operations Department and the Practice to provide timely, proficient services for all patients whose research activities are conducted under FDA and Good Clinical Practice Guidelines. Implements, coordinates, and maintains all research projects approved by the Practice.

We have a full-time opening for a Clinical Research Coordinator to join the team at our Pembroke Pines, FL office. The schedule is Monday-Friday 7:30am-4:00pm, with the ability to float to the Margate office as needed.

How You'll Contribute :

We always do whatever it takes, even if it isn't specifically our "job." In general, the Clinical Research Coordinator is responsible for :

I. Essential Functions

Research :
• Assists with investigational study selection and project negotiation, including initial site / sponsor correspondence, budget preparation, regulatory document preparations for protocol and IRB submission
• Provides quality clinical care and educates patients on the fertility process
• Performs clinical activities and administrative work in support of the research study
• Attends required study meetings and remains current on procedures & protocols
• Develops standard study operation procedures for IVF Florida
• Provides training tools and information for Nurses, Medical Assistants, Sonographers, and other clinical & administrative staff as needed
• Conducts study consultations with patients
• Obtains and maintains informed consents
• Maintains and completes data collection
• Dispenses medications and maintains investigational product accountability
• Prepares for and coordinates CRI site visits and inspections
• Handles regulatory reporting including adverse events and case report forms

Clinical / Technical :
• Participates in medication administration
• Performs routine patient assessment if needed (height, weight, vital signs, etc.)
• Assists physicians with procedures, exams as needed
• Documents patient care services by charting in patient and department records including the FERT Clinical Information System
• Maintains safe and clean working environment by complying with procedures, rules, and regulations, and calling for assistance from other health care support personnel when appropriate
• Protects patients and employees by adhering to infection-control policies and protocols, medication storage procedures, and controlled substance regulations
• Ensures operation of equipment by following manufacturer's instructions. Reports problems or malfunctions to appropriate staff member

Patient Interaction :
• Provides patient / couple counseling, OI / IVF procedure teaching, and scheduling of treatment after initial and follow-up visits for study patients
• Coordinates patient treatment plans in conjunction with established clinical protocols
• Monitors cycling visits for study patients including: medication instruction (schedule, dosage and administration), anticipatory guidance, and clarification of physician instructions
• Communicates physician and RN orders and instructions
• Communicates laboratory results with appropriate interpretation and explanation
• Coordinates scheduling of cycles and procedures with study patient and appropriate staff (financial, labs, OR supervisor, etc.)
• Monitors for scheduling of ER, ET, and other in-house surgical procedures for study patients as needed. Provides pre and post op education
• Establishes a compassionate environment by providing emotional and psychological support to patients and patients' families
• Assures quality care by adhering to therapeutic standards; follows physician practice and nursing division philosophies, as well as standards of care set by the state and other governing agency regulations

Team Communication :

1. Clinical Operations Department
• Provides appropriate documentation of patient care via FERT Clinical Information System and other forms as needed
• Reviews and abstracts patient records
• Accepts resource assignment; assists all staff with information of area assigned
• Works weekends and holidays as needed

2. Practice
• Makes referrals to other team members
• Attends meetings as assigned; communicates issues where appropriate
• Cooperates, interfaces and works independently to assure the program goals are achieved

Administrative :
• Oversees assigned staff within a designated area of a Department's operations
• Helps to plan and organize the responsibilities of assigned staff to increase efficiency and best utilize the staffs' skills and abilities
• Helps to set goals for assigned staff and motivates staff to accomplish the goals
• Ensures adequate staffing and that assigned staff are present and working
• Assists with interviewing potential employees
• Assists with time keeping and payroll duties. Tracks leave requests to ensure proper documentation of employee's time. Maintains calendar, recording staff leave dates to monitor for adequate coverage of teams and/or offices
• Supervises and redirects assigned staff as needed to improve operational efficiencies and service delivery
• Assists with processing patient or program incidents within designated area and helps to prepare necessary documentation
• Assists in the orientation of new staff and training existing staff on new or revised program policies and procedures. Plans for in-services / educational opportunities
• Under the direction of the Director, conducts individual supervision / counseling sessions for assigned staff and completes all necessary documentation
• Writes and administers performance appraisal evaluations for assigned staff under the supervision of the Director
• Works with assigned staff to correct performance problems using SGF Services' established system
• Assists in addressing and resolving day-to-day issues that pertain to the research department
• Attends all required management and financial meetings

Professional Development :
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks
• Participates in professional societies
• Follows all state regulations regarding professional license as applicable

II. Confidential and Sensitive Information
• Maintains patient confidence and protects operations by keeping all patient information confidential

III. Scope of Financial Responsibility
• Utilizes financial department to provide appropriate information to patients and ensures that patients are financially cleared before beginning of treatment

What You'll Bring :

The skills and education we need are :
• Graduate of an accredited college / university with a Bachelor's Degree in a scientific discipline or health related field OR an Associate Degree in a scientific discipline or health related field and three years experience is required
• Minimum 3 years' experience in women's health and infertility experience preferred
• Registered Nurse preferred
• Certified Clinical Research Coordinator (ACRP or SOCRA) or minimum of 2 years experience and training in the conduct of clinical research studies (IRB submissions, reporting, source documentation & trial management) preferred
• Ability to access, input, and retrieve information from a computer
• Current CPR certification, or acquire within 1 month of employment
• Knowledge of office procedures and office machines (i.e., computer, fax, copier, etc.)
• Ability to work as part of a multidisciplinary team and autonomously
• Ability to communicate accurately and concisely; excellent interpersonal skills
• Proven ability to meet deadlines and follow-through on projects
• Ability to work independently to manage a caseload of patients

More important than the best skills, however, is the right person. Employees who embrace our mission, vision, and core values are highly successful.

What We Offer :

We are proud to provide a comprehensive and competitive benefits package tailored to support the needs of our team members across all employment types :
• Full-Time Employees (30+ hours / week) : Medical, dental, and vision insurance, 401(k)
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