1. Complete compliance requirements on an annual basis.

2. Maintain Supplies to the department within budgetary parameters

3. Interact in a positive manner with other departments within the corporate office to facilitate the departmental projects.

4. Demonstrates a commitment to department objectives through consistent patterns of work behavior and positive representation.

5. Provides prompt, courteous, professional, and accurate information in all communications in dealing with physicians and other departments.

6. Responds to the department needs by accepting additional assignments, which may or may not be related to the job's primary responsibilities to ensure the continuity of department services.

7. Responsible for following all facility, organization and department precautions and procedures in the performance of all job duties to ensure a safe work environment for self and others.

Performance Evaluations: Conduct performance evaluations as per standards of Pediatrix Medical Group for full time, part time and contract monitors of clinical trials.

1. Establish goals and performance objectives with the employee.

2. Conduct ongoing progress reviews.

3. Provide support to facilitate employee meeting their goals.

4. Conduct annual performance review .

Clinical Trials: Provide clinical monitoring expertise, support, and leadership for more junior clinical research staff.

1. Provide CRA education and training for specific projects.

2. Communicate new developments in clinical research to CRA's.

3. Provide support in all areas of the trial(s) to field monitors.

4. Review paperwork submitted by field monitors to ensure compliance with the project.

5. Conduct on site evaluations with field monitors.

6. Conduct evaluation/surveys of field monitors with clinical site personnel.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

1. Site Selection: Assists with the identification and contacting of potential investigators; ensures adequacy of clinical research staff/facilities with regard to Pediatrix Medical Group, SOPs, and global regulatory requirements.

2. Study Initiation: Conduct site initiation visits. Ensure essential regulatory documents are in place; review investigator responsibilities; review the protocol and CRF; coordinate shipment of study-related materials if necessary; assist in the preparation for and attend investigator meetings.

3. Study Monitoring: On-site Monitoring: a. Site contact and notification of visit. b. Assesses overall investigator site performance by ensuring compliance with GCPs and SOPs. c. Verify use of IRB approved Informed Consent Form. d. Ensure investigator and staff adherence to protocol and initiate action to resolve issues. e. Ensure essential regulatory documents are available and current. f. Review CRFs for completeness and accuracy and ensure that corrections are made appropriately .g. Perform source document verification. h. Perform query resolution procedure if applicable i. Review Adverse Events and/or Serious Adverse Events and follow reporting procedures to Pediatrix Medical Group/Sponsor. j. Track progress of study enrollment and assist in patient recruitment detailing actions and findings. k. Assist in resolving site problems (i.e., enrollment issues).l. Ensure Clinical Trial Material (CTM) accountability. m. Provide Pediatrix Medical Group/Sponsor with monitoring report after each visit. n. Document visit on monitor log in trial manual.

4. In-house Monitoring: a. Maintain regular telephone contact with site(s).b. Maintain written correspondence with site(s). (Use of email should be retained.)c. Keep Director of Clinical Services fully appraised of site and study status. d. Record Serious Adverse Events .e. Performs query resolution via site contact.

5. Study Termination: a. Perform any outstanding query resolution. b. Retrieve case report forms. c. Ensure regulatory documents are available and current. d. Ensure clinical trial material accountability, return, and disposal as applicable. e. Review record retention requirements with the Investigator and study personnel. f. Review and secure investigator's final report against Pediatrix Medical Group SOPs. g. Provide Pediatrix Medical Group/Sponsor with Study Termination monitoring report detailing findings and issues that require resolution.

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES:

Develop and perform testing modules for trial specific electronic case report forms.

Develop and write SOPS or other trial related documents that may be needed.

Perform administrative duties including attendance at clinical trial staff meetings and project team meetings.

Provide 24-hour coverage for multi-center trial staff.

Possess knowledge of and ability to use the PDX Research Data System.

Maintain awareness of the overall development in the field of clinical research as well as assigned areas.

Attend professional meetings, seminars, or conferences.

• Education required: Bachelor's Degree in a health related field.
• Education preferred: RN, BSN, RRT with clinical experience or master's degree or similar education in a clinical field, clinical research administration, or
  business administration.
• Health care or research related experience or equivalent combination of education and experience. Excellent verbal and written communication skills; ability to work independently; knowledge of computers are preferred. Must be willing to travel.
• Certifications preferred: Society of Clinical Research Associates Certification (SoCRA) or Association of Clinical Research Professionals Certification (ACRPCP Certification), Certified in Healthcare Research Compliance
  (CHRC)

Benefits for Full Time employee and qualified dependents:

• Health Insurance including prescription drugs
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short- and Long-Term disability options
• Employee stock purchase program - 15% discount*
• 401k with company match**
• Long Term Care (LTC)
• Pre-tax Health Savings Account (HSA)
• Pre-tax Flexible Spending Accounts (FSA)
• Aflac Hospital, Critical Illness and Accident plans
• Identity Protection
• Employee Assistance Program (EAP)

*Part Time Regular employee classifications also receive this benefit.

** Available to part-time regular and part-time casual employees age 21 and over.

Pediatrix Medical Group, Inc. (Pediatrix) is the nation's leading provider of physician services. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. Specialties include obstetrics, maternal-fetal medicine and neonatology complemented by more than 20 pediatric subspecialties, as well as pediatric primary and urgent care clinics. The group's high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. The physician-led company was founded in 1979 as a single neonatology practice and today provides its highly specialized and often critical care services through more than 5,000 affiliated physicians and other clinicians in 37 states.

Please Note: Fraudulent job postings/job scams are becoming increasingly common. All genuine Pediatrix job postings can be found through the Pediatrix Careers site: .

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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