Clinical Research Director Assistant

Type of Requisition :

Regular

Clearance Level Must Currently Possess :

None

Clearance Level Must Be Able to Obtain :

None

Suitability :

Public Trust / Other Required :

NACI (T1)

Job Family : Program Management

Program Management

Job Qualifications : Skills :

Skills :

Clinical Research, IRB, ResearchingCertifications :

Experience :

5 + years of related experienceUS Citizenship Required :

Job Description :

GDIT's Military Health Team is hiring a Clinical Research Director Assistant to support the 59th Medical Wing located at Lackland Airforce Base in San Antonio, TX.

The 59th Medical Wing Science and Technology (ST) office advises and conducts clinical and translational research on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries.

In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.

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HOW A PROGRAM ANALYST WILL MAKE AN IMPACT

Assists in institutional research for the 59th Medical Wing.

Assists in operations of the IRB and preparing protocols to go through the board process.

Works with investigators in preparing and reviewing protocols ensuring protocols meet all applicable Air Force, DoD, and Federal requirements.

Manages data collection and analysis and oversees the formulation of research reports (i.e., reports to higher headquarters, accrediting agencies, research partners, etc.)

Assists presiding member of the Wilford Hall Medical Center IRB to develop processes to review and coordinate all research protocols in accordance with the Common Rule, Belmont Report, and other federal, DoD and AF regulations.

Assists in developing and writing operating instructions for all processes associated with performing research within the institutions.

Acts as an appointed non-voting member of the IRB.

Determines category of IRB approval required for studies submitted.

Assists in preparing IRB agenda working with the IRB Presiding Member and IRB protocol staff and publishes agenda.

Assists in tracking all ongoing approval and concurrence actions from Higher Headquarters and coordinates actions with principle investigators, IRB members, and Division personnel.

Assists in controlling protocol documentation, establishing suspense’s and ensuring documentation is complete and prepared for scheduled IRB meetings.

Assists in completion and review of IRB minutes, reviewing for completeness and thoroughness prior to submission for signature and coordination with higher headquarters review.

Assists in ensuring minutes contain all pertinent information relevant to risk determination and regulatory compliance to expedite review by outside compliance agencies.

Assists in tracking training and compliance issues of all individual investigators involved in research in the 59th Medical Wing, ensuring appropriate training is completed as required and that a;

personnel meet compliance regulations pertaining to research being conducted within the control of the WHMC IRB.

Assist IRB Chair and Presiding Official in conducting meetings ensuring required members are available, votes are cast and conflict of interest issues are resolved in accordance with commonly accepted rules of order.

Review protocol changes submitted to the IRB required changes and assists in approval and concurrence actions from the Air Force Surgeon General's Office.

WHAT YOU’LL NEED TO SUCCEED :

Bachelor of Science Degree with 5+ years of experience in clinical research or a Master’s / PhD in scientific field with 2+ years.

Documented authorship of scientific publications, conducting clinical research to include experience in developing and designing research protocols or experience with research compliance and auditing is required.

Experience and broad knowledge of medical, nursing or allied health care fields used to interpret research functions.

Working general knowledge of various medical specialties to thoroughly understand the primary ideas / intent outlined in protocol documents and is able to identify and recommend modifications to correct issues or inconsistencies.

Experience or knowledge of research methodology and experimental design to ensure that protocols are properly developed to meet all compliance guidelines.

Experience and ability to clearly articulate objectives, recommendations and decision, to prepare and present materials and other literature designed for the research process.

Effective interpersonal relation skills to diplomatically deal with novice and seasoned researchers in a number of medical specialties.

Ability to assist in the planning, organizing and administering a variety of programs and activities related to research protocols.

Recent knowledge (within 5 years) of research compliance guidance as outlined in the Office of Human Research Protection (OHRP) and Office of Laboratory Animal Welfare (OLAW) policies and regulations.

Knowledge of DoD or AF guidance and regulations or 3 years of actual research experience can substitute for OHRP and OLAW experience.

The Contractor Personnel shall have and maintain a current Basic Life Support (BLS) certification.

Intermediate+ experience with Microsoft Office applications including : Word, Excel, PowerPoint, and Outlook.

GDIT IS YOUR PLACE :

401K with company match

Comprehensive health and wellness packages

Internal mobility team dedicated to helping you own your career

Professional growth opportunities including paid education and certifications

Cutting-edge technology you can learn from

Rest and recharge with paid vacation and holidays

The likely salary range for this position is $60,549 - $69,000. This is not, however, a guarantee of compensation or salary.

Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours :

Travel Required : None

None

Telecommuting Options :

Onsite

Work Location : USA TX Lackland AFB

USA TX Lackland AFB

Additional Work Locations :

Total Rewards at GDIT :

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match.

To encourage work / life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.

To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available.

We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.

S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation.

We operate across 30 countries worldwide, offering leading capabilities in digital modernization, AI / ML, Cloud, Cyber and application development.

Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

We connect people with the most impactful client missions, creating an unparalleled work experience that allows them to see their impact every day.

We create opportunities for our people to lead and learn simultaneously. From securing our nation’s most sensitive systems, to enabling digital transformation and cloud adoption, our people are the ones who make change real.

GDIT is an Equal Opportunity / Affirmative Action employer. 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, or any other protected class.