Position Focus:

The Clinical Epidemiology Research Center (CERC) located on the West Haven campus of VA Connecticut Healthcare System is a patient-oriented research center in the Veterans Affairs (VA) Cooperative Studies Program (CSP). The CERC broadens the capability of the Cooperative Studies Program Coordinating Center (CSPCC) at West Haven by providing expertise in multisite observational (non-randomized) studies. Under the direct supervision and reporting to the Director of the CERC, the incumbent functions as a project leader/manager or coordinator for assigned epidemiological research studies performed under the auspices of the center and is responsible for the administrative and operational activities of these projects during their various phases:

• Coordinates and participates in the planning, data collection and data analysis for multifaceted research projects in the "non-wet" lab phases of clinical medicine.
• Performs independent research and analyses.
• Conducts research by developing protocols for the collection of data and designing data collection instruments.
• May conduct structured or semi-structured interviews and administer data collection instruments in support of research projects of varying magnitude and complexity.
• Designs and implements quality control measures to ensure the efficient and accurate collection and processing of data.Compiles and analyzes results.
• Composes status reports and analyses related to the study.

The individual will be responsible for managing all administrative aspects of the study, overseeing the planning of the study, establishing strategies to meet financial parameters, training requirements, and productivity goals, while acting as the primary interface between the participating centers and the support centers. Manages the study budget and makes decisions related to the budget. Projects and reports anticipated yearly expenditures. Prepares documents for various agencies and internal committees for approval of new studies or re-approval of existing studies. Coordinates and manages contracts with outside vendors/sponsors. Initiates and coordinates public awareness and information on the studies.

Provides guidance to the principal proponent and biostatistician in the development of the final protocol and informed consent form. In conjunction with Principal Investigator, develops protocols for collection of data for research projects; designs data gathering instruments and related procedures; tests, refines and finalizes instruments for use in the research study. Designs and develops logs, files, records, questionnaires and other related materials to obtain data and maintain records. Determines procedures for data collection which are consistent with outside organizations and the research projects. Supervises and coordinates research data which includes the collection, verification and processing of data for study subjects. Oversees day-to-day operation of the research project or projects. Assists in preparing protocol submission to the Cooperative Studies Evaluation Committee and in the preparation of the Study Operations Manual for conducting the study. Prepares and presents the administrative and budgetary procedures to study participants at the annual meetings.

Provides mentoring/training for new study team staff and project managers. Coordinates and conducts regular meetings with staff, principal investigators and the study collaborators to ensure that the goals and objectives are being met. Reviews with principal investigator study results to ensure the validity of the research projects. Writes periodic reports to the funding agency; jointly submits papers for publication. Ensures compliance with regulatory guidelines established by government agencies. Consults with the CERC/CSPCC Quality Assurance Specialist for guidance on specific issues of patient safety, confidentiality and rights, and trial management that arise during the course of the trial.

Essential Duties

1. Supervises research within the scope of established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
2. Responsible for reviewing, planning, and implementing study protocols and assessing the impact of program changes on research quality. Identifies and makes initial contact with potential funding sources to secure funds.
3. Oversees the planning of large multi-site or global studies. Establish goals and objectives, training requirements, productivity goals and financial parameters. Develops forms and questionnaires and manages the application of research techniques.
4. Works closely with research faculty and collaborators to identify quality and operational strategies and aspects of study that need to overcome.
5. Fosters and maintains cooperative relationships with principal investigators, collaborators, study coordinators, government officials, international partnerships, and study sponsors to ensure for the safe and timely progression of studies and adherence to all study/agency/government regulations.
6. Develops original HIC/IRB submissions for multi site research. Collaborate with various PI on major revisions and ensure changes are incorporated at each participating site.
7. Uses advanced statistical knowledge to provide support in managing and analyzing data.
8. Develops operational procedures for the collection, editing, verification and management of statistical data. Develops and implements relevant statistical programs to incorporate data from multiple projects. Designs comprehensive and rational databases with advance knowledge of the scientific applications impacting on the data analyses and reporting.
9. Develops protocols for collection of data. Designs data gathering instruments and related procedures. Tests, refines and finalizes instruments for use in research study.
10. Presents talks, seminars or other oral presentations on the methodology and analyses used in scientific studies.
11. Composes major abstracts/publications/manuscript.
12. May perform other duties as assigned.

Required Education and Experience

Master’s Degree in a related discipline and four years of experience or an equivalent combination of education and experience.

Required Skill/Ability 1:

Knowledge, skills and techniques gained from professional training in a health science or allied scientific field. Detailed knowledge of professional medical research.

Required Skill/Ability 2:

Knowledge of advanced IT to properly utilize the automated systems designed to carry out epidemiological research. Knowledge and skill in applying analytical and evaluative methods and techniques to issues or studies concerning the efficiency and effectiveness of program operations.

Required Skill/Ability 3:

Knowledge of pertinent laws, regulations, policies such as the CSP Guidelines and Standard Operating Procedures. Skill in conducting detailed analyses of complex functions and work processes. Ability to coordinate multiple activities among multiple studies. Ability to work independently with limited supervision.

Required Skill/Ability 4:

Interpersonal skills, public speaking skills and ability to negotiate contracts. Excellent critical and strategic thinking skills. Extremely detail-oriented. Highly self-motivated, independent, consistent, and reliable.

Required Skill/Ability 5:

Willing to travel a portion of the time depending on the needs of the program and possibly be stationed. Requires a Without Compensation (WOC) appointment at the VA. Advanced proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Required Licenses or Certifications
HSPT, HIPAA, GCP certificates are to be obtained on the job.

Preferred Licenses or Certifications:
CCRP certification is a plus.

Weekend Hours Required?
Occasional

Evening Hours Required?
Occasional

Drug Screen
No

Health Screening
No

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.

Additional Background or Health Screening Requirements

Selected incumbent must have successful completion of a federal and/or state background check investigation, in addition to the University background check.

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.

Affirmative Action Statement:

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: ocr.boston@ed.gov.

Note

Yale University is a tobacco-free campus