***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION***
This is a term appointment not to exceed 1 year 1 day. Term appointments are non-status, nonpermanent appointments of limited duration of more than 1 year, but not more than 4 years and are subject to a 1 year trial period. Should the need warrant, term appointments may be extended without further competition up to a maximum of the 4 year limitation. The appointment to a term position does not confer eligibility for promotion, reassignment, or transfer to other positions or the ability to be non-competitively converted to permanent employment.
This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds.
Major duties and responsibilities include but not limited to:
Manages Clinical Tests and Collects Data
Managing implementation, control and reporting on clinical tests and data collection for difficult clinical research studies
Recording data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study
Coordinating the accomplishment of the scientific review and evaluation of research programs
Participating in initial classification and coding of qualitative/quantitative data and entering coding data into qualitative/quantitative software
Assisting with data analysis from a variety of sources, including databases and spreadsheets, and conceive and write reports
Respond to inquiries from a sponsor, clinical research coordinating center and/orsite Pl on matters related to data, data compliance, and subject complaints related to data collection
Creating and maintaining complex research databases, working with existing VA administrative databases, and managing spreadsheet files for data tracking, budget tracking, and other project management tracking tasks
Recording and maintaining results and records of all tests or assessments as per protocol and in a manner complying with research regulations
Developing and maintaining/updating study database in accordance to sponsor and/or Pl's specifications. Assist Pl with data analyses and interpretation
Recruits and Manages Candidates for Clinical Trials
Overseeing, screening, and evaluating recruitment of candidates for clinical research studies via telephone and/or in person
Using objective rating techniques to identify potential candidates for participation in study where project design is complex
Overseeing recruitment and enrollment of participants, providing information on study objectives and constraints
Performing informed consent process throughout the study and continuously educate participants on study processes and procedures
Obtaining verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information from patients
Performing day-to-day activities related to conducting and overseeing participant interviews and follow-up
Coordinating study participant randomization to treatment, works closely with the Research Pharmacy on study drug provision
Identifying study adverse events and side effects, symptoms which might require intervention or referrals
Research Project Support
Assisting supervisor with managing the routine, day-to-day activities, and administration of the project
Analyzing processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations
Conducting quality assurance evaluations for project data and clinical research instruments
Providing technical guidance to research staff regarding regulations, policies, and procedures applicable
Responding to general inquiries from program participants, staff, and other stakeholders
Managing participant compensation, maintain compensation records, and prepare invoices or electronic funds transfer for reimbursement of participants
Assisting in the development of clinical research standard operating procedures/policies and implementation of administrative procedures
Organizing and maintaining all study documents for management, data, record keeping and/or compliance purpose
Administering screening, advisory and approval processes for the organization's health science research program
Performing a variety of duties to maintain specialized data and implement study design.
Work Schedule: Monday to Friday; 08:00 a.m. to 04:30 p.m.
Recruitment & Relocation Incentives: Not authorized
Critical Skills Incentive (CSI): Not Approved
Starting at $59,966 Per Year (GS 9)
