Research Supervisor-Woodward/TRI Clinical Trials, (1295)

Schedule: Monday-Friday 0830-1700 with weekends, holidays and other shifts as needed

Location: Woodward/TRI Clinical Trials

Hourly/Salary: Salary

JOB SUMMARY:

Responsible for the technical and/or staff performance of their research section. Monitors Quality Control, proficiency, and competency testing, as needed. Participate as effective team member in section management relative to communications, operations, finances, and personnel as appropriate. Assist the Manager, or Director and appropriate Medical Director(s) in meeting customer expectations. Work closely with appropriate medical director(s) regarding decisions on matters relating to research work, team performance, quality improvement, and finances.

ESSENTIAL FUNCTIONS:

1. Research Operations

a. Provide assistance in the request, implementation, or initiation of new research studies, collections, or procedures. Interpret, submit, or manage data with the relevant medical director, principal investigator, and/or manager, as needed.

b. Research and resolve problems and/or assist others in resolving problems appropriately.

c. Consult with medical director, principal investigator, supervisors or managers regarding protocol deviations, abnormal findings or conflicting or discrepant results.

d. Ensure maintenance on instruments is performed as needed or appropriate.

e. Participate in developing/implementing system improvements for department or research processes.

f. Work with Information Technology (IT) department to conduct security risk assessments and audits, to maintain research network, and to ensure computer file maintenance for relevant research data is correct and up to date.

g. Maintain and update department procedure manuals as needed or appropriate. Develop new procedures and special reports as needed.

h. Be competent to perform appropriate work in the section.

2. Quality Assurance (QA) /Quality Control (QC)

a. Responsible for Quality Control performance is acceptable per Good Laboratory Practice and individual project protocols (including maintenance and temperature charts). Ensure that monthly reports are prepared and reviewed.

b. Assist in development, monitoring and reporting of Quality Assurance standards and objectives, according to research protocols and regulations.

c. Participate in QA programs to ensure that Quality standards are met. Continually evaluate the needs and expectations of the customers and implement new quality processes to ensure that these expectations are met or exceeded.

d. Serve as consultant for QA/QC problem situations; work to resolve situations as they occur so that research may continue in a timely manner.

3. Compliance

a. Implement, maintain, and document standard and research laboratory procedures to ensure quality research results, and the safety and security of personnel and property. Ensure section compliance with all regulatory agencies and inspections.

b. Prepare for and host onsite inspections or audits by certification or qualification agencies, and study sponsors, including CAP, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), FDA, IRB, Clinical Research Organization (CRO), etc.

c. Ensure required research training is completed as scheduled.

d. Monitor and document protocol deviations, adverse events, and serious adverse events. Report to regulatory agencies and IRB, as necessary. Initiate incident tracking system documentation and corrective action as needed.

4. Training

a. Establish, maintain, and document appropriate training and competency programs to ensure that all employees are trained and understand the expectations of the section.

b. Ensure that new hires, students, are trained appropriately in the area(s) of research specialty as needed or appropriate.

5. Budgeting / Inventory Control

a. Provide appropriate inventory control. Review invoices and forward for approval as appropriate.

b. Participate in preparing and meeting budgets for personnel, supplies and capital equipment needed for the section. Assist with cost accounting of supplies and labor for specific work performed in the section.

6. Organizational / Employee Development

a. Supervise and evaluate the research work of staff working in the section.

b. Communicate regularly with employees regarding their performance.

c. Prepare and perform employee performance evaluations and disciplinary actions with staff following TriCore policies.

d. Review and prioritize workload and work to match staffing to meet workload. Prepare/oversee the preparation of staff work schedules.

e. Participate in hiring decisions, including job postings, reviewing applications, and interviewing applicants. f. Actively solicit staff input and feedback. Listen with the purpose of understanding employee concerns, questions, ideas, and opinions.

g. Actively support and implement department procedures, polices and strategies to support the corporate vision, values, and strategic plans.

h. Assist with marketing of the section(s)’ services through client contact, providing information for marketing brochures, and tours to community groups as appropriate.

i. Communicate with department management team and staff to ensure appropriate sharing of information.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Many duties are study or project specific and will vary. MINIMUM

EDUCATION

Bachelor Degree.

o Must have education and training equivalent that includes:

? A degree in a health-related field o Have research training that includes documented training in each section in which the individual oversees.

MINIMUM EXPERIENCE:

? Four years’ experience in area of research specialty.

OTHER REQUIREMENTS:

? Basic supervisory experience required. ? ASCP or equivalent certification for section.

PREFERENCES:

? Specialty and/or Research certification.

IMMUNIZATION REQUIREMENTS:

Prove immunity to Hepatitis B or be immunized or sign a waiver refusing hepatitis immunization. Provide documentation of a PPD test conducted not more than 90 days prior to date of hire or have a PPD test conducted. IN DEPARTMENTS/LOCATIONS WITH DIRECT PATIENT CONTACT: Prove immunity or be eligible to receive rubella, rubeola and varicella immunization.

GENERAL REQUIREMENTS:

1. Handle special projects as needed or directed.

2. Facilitate and/or participate in Quality Management Teams as needed or appropriate.

3. Maintain an up-to-date knowledge of clinical research through self-study and participation in continuing education programs.

4. Maintain CITI certification in Good Clinical Practices and others, as assigned.

5. Attend department and supervisory meetings as scheduled.

6. Work closely with appropriate medical/scientific director(s) regarding decisions on matters relating to research work, team performance, quality, and finances. This may include, but is not limited to, such matters as capital, methodology and budget. Also, decisions on matters relating to key personnel.

7. Other duties as assigned.

8. Handles hazardous materials and wastes in accordance with safety procedures and regulations. Specific training requirements are documented in TriCore’s Waste Management Plan, SAF-011.

9. Good organizational skills

10. Moderate PC knowledge/skills

11. Training skill/experience

12. Leadership skills/experience

13. Strong communication skills. Ability to listen effectively and to deal with difficult situations effectively.

14. Ability to solve complex problems and communicate solutions appropriately.

15. Be flexible and adaptable to change.

16. Ability to deal effectively with clients, customers, sponsors, principal investigators, and all internal and external customers.