Health Science Specialist
Duties Project Management 1. Responsible for managing all administrative aspects of 2 to 3 trials, while acting as the primary interface between the sponsors and investigative institutions (sites). 2. Manages the trial budgets and makes decisions related to the budgets. Projects anticipated yearly expenditures, and reports these to the ADO. 3. Aids Principal Proponent in the development and revision of the final protocol and informed consent form and study Operations Manual. Prepares final proposal and all submissions to CSSMRB. 4. Ensures/monitors that each site receives an annual review of study documents and approval for study continuation by their institutional IRB, and maintains documentation of these reviews in the sponsor's files. 5. Specifically assigned to startup of new studies in conjunction with the ADO. 6. Ensures compliance with regulatory guidelines established by government agencies (FDA, OHRP, VA). 7. Consults with appropriate regulatory agencies for guidance on specific issues of patient safety, confidentiality and rights, and trial management that arise during the course of the trial. 8. Works closely with study sites and addresses any problems that arise, such as, loss or changes in study staff, poor enrollment, non-compliance with protocol or regulatory requirements, poor trial/patient management, and serious issues related to patient safety. Training/Communication 1. Leads standardization efforts for project management group by assisting with development, review, implementation, and maintenance of project management SOPs and work practice guidelines by working with project management group members and other Center staff as needed. 2. Acts on behalf of the Chief Project Management group leader to train junior project management staff on regulatory requirements, budget development and maintenance, and general trial management. 3. Has primary responsibility for developing training materials for project management staff. 4. Has primary responsibility for developing template language to be used in protocols, operations manuals, and informed consent forms as it relates to human subject protections. Strategic Planning 1. Assists the Chief Project Manager and other Senior Leadership in evaluating efficiencies, existing policies and determining areas for improvement 2. Participates in program-wide discussions regarding project management and communicates with other CSP centers regarding best practices. M This is a TERM appointment (not-to-exceed 2 years). Term appointments are non-status, nonpermanent appointments of limited duration (more than 1 year but not more than 4). Term employees are eligible to earn leave and generally have the same benefits as permanent employees including health and life insurance, within-grade increases and Federal Employees Retirement System and Thrift Savings Plan coverage. Term appointments may be extended without further competition (up to the 4 year maximum). The appointment to a Term position does not confer eligibility for promotion or reassignment to other positions or the ability to be non-competitively converted to permanent employment. Work Schedule:
M-F 8:
00am - 4:
30pm Recruitment & Relocation Incentives:
Not authorized Financial Disclosure Report:
Not Required Telework:
This position is telework eligible. BASIC EDUCATION REQUIREMENT:
You must first meet Basic Education Requirements for this position. Possess a Bachelor's degree or graduate/higher level degree:
with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of a Health Science Specialist. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. PLUS In addition to meeting the Basic Education requirement, you must also possess specialized experience as indicated below in order to qualify for this position GS-12 Grade Requirements In order to meet the minimum qualifications for this position at the GS- 12 level you must possess at least one (1) full year of specialized experience, equivalent to at the least the next lower grade level (GS-11), that equipped you with the particular knowledge, skills, and abilities to perform successfully the duties of the a Health Science Specialist. Specialized experience is experience where you applied mastery of the principles, concepts, methods, and techniques of related to the performance of clinical research; providing feedback to others related to clinical research processes; and assisting in conducting research-related data analysis, developed policies, procedures, and criteria for the administration of the health science research program; communicated, both orally and in writing, to make presentations, explain recommendations, provide guidance, responded to inquiries and prepare reports; worked with budgeting procedures and use of capitation payments. Preferred experience as a Project Manager, preferably with experience working on multiple protocols. Note:
Experience must be fully documented on your resume and must include job title, duties, month and year start/end dates AND hour worked per week. OR Possess a Ph.D. or equivalent doctoral degree or equivalent graduate degree which demonstrates the knowledge, skills, and abilities necessary to do the work of this position. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL/UNOFFICIAL TRANSCRIPTS REQUIRED) OR An equivalent combination of creditable experience and education as described above to meet the requirements for this position at the next lower grade level. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL/UNOFFICIAL TRANSCRIPTS REQUIRED) You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Administration and ManagementCommunicationsResearch IMPORTANT:
A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
Estimated Salary: $20 to $28 per hour based on qualifications.
M-F 8:
00am - 4:
30pm Recruitment & Relocation Incentives:
Not authorized Financial Disclosure Report:
Not Required Telework:
This position is telework eligible. BASIC EDUCATION REQUIREMENT:
You must first meet Basic Education Requirements for this position. Possess a Bachelor's degree or graduate/higher level degree:
with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of a Health Science Specialist. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained. PLUS In addition to meeting the Basic Education requirement, you must also possess specialized experience as indicated below in order to qualify for this position GS-12 Grade Requirements In order to meet the minimum qualifications for this position at the GS- 12 level you must possess at least one (1) full year of specialized experience, equivalent to at the least the next lower grade level (GS-11), that equipped you with the particular knowledge, skills, and abilities to perform successfully the duties of the a Health Science Specialist. Specialized experience is experience where you applied mastery of the principles, concepts, methods, and techniques of related to the performance of clinical research; providing feedback to others related to clinical research processes; and assisting in conducting research-related data analysis, developed policies, procedures, and criteria for the administration of the health science research program; communicated, both orally and in writing, to make presentations, explain recommendations, provide guidance, responded to inquiries and prepare reports; worked with budgeting procedures and use of capitation payments. Preferred experience as a Project Manager, preferably with experience working on multiple protocols. Note:
Experience must be fully documented on your resume and must include job title, duties, month and year start/end dates AND hour worked per week. OR Possess a Ph.D. or equivalent doctoral degree or equivalent graduate degree which demonstrates the knowledge, skills, and abilities necessary to do the work of this position. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL/UNOFFICIAL TRANSCRIPTS REQUIRED) OR An equivalent combination of creditable experience and education as described above to meet the requirements for this position at the next lower grade level. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL/UNOFFICIAL TRANSCRIPTS REQUIRED) You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Administration and ManagementCommunicationsResearch IMPORTANT:
A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
- Department:
0601 General Health Science - Salary Range:
$85,428 to $111,062 per year
Estimated Salary: $20 to $28 per hour based on qualifications.
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