- Writes protocol applications and consent forms for Institutional Review Boards. Prepares and submits required institution and federal documentation for the conduct of the trial.
- Manages regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintains accurate, regulatory-compliant program/study binders.
- Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions.
- Negotiates contracts and develops cost-per-patient study budgets.
- Coordinate's efforts of all agencies involved in the protocol approval process. Makes and maintain contacts within the pharmaceutical industry.
- If applicable: May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
- May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.
- Bachelor's Degree
- Minimum of 0-2 years experience required
- Working knowledge of a broad range of medical specialties.
- Working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e,g,; 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 14, 45 CFR 46, FDA Form 1571, and FDA Form 1572).
- Must be familiar with Institutional Review Board activities and Institutional Bio-safety Committee actions.
- Must be able to set and meet deadlines.
- Lifting: Requires lifting materials up to 25 lbs.
- Ability to stand or sit at a computer for prolonged periods
- This position will take place primarily in a clinic setting.
-
Research Coordinator
2 days ago
University of Maryland College Park, United States**Posting Details**: · - Posting Details**Position Number**: · **Title**: · - Coordinator**Functional Title**: · - Research Coordinator**Category Status**: · - 33-Exempt Regular**Applicant Search Category**: · - Staff**University Authorized FTE**: · - 1.000**Unit**: · - CMNS-Eart ...
-
Research Data Coordinator I
1 week ago
Georgetown University Washington, United StatesLocated in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals i ...
-
Clinical Research Coordinator
1 week ago
Veear Projects Inc Bethesda, United StatesDeliverables: Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc · Manage conflicts/issues in clinical research s ...
-
Clinical Research Coordinator
1 week ago
Guidehouse Bethesda, United StatesJob Family: · Research Analyst (Digital) · Travel Required: · None · Clearance Required: · Ability to Obtain Public Trust · What You Will Do: · We are currently searching for a Clinical Research Coordinator to provide clinical research coordination through the NINDS Clinical Tria ...
-
Clinical Research Coordinator
1 week ago
Guidehouse Bethesda, United StatesJob Family: · Patient Care Coordinator (Digital) · Travel Required: · None · Clearance Required: · Ability to Obtain Public Trust · What You Will Do: · We are currently searching for a Clinical Research Coordinator to provide clinical research coordination and protocol navigation ...
-
Clinical Research Coordinator
1 week ago
Veear Projects Inc Bethesda, United StatesDeliverables: Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc · Manage conflicts/issues in clinical researc ...
-
Clinical Research Coordinator
6 days ago
Guidehouse Bethesda, United StatesJob Family: · Patient Care Coordinator (Digital) · Travel Required: · None · Clearance Required: · Ability to Obtain Public Trust · What You Will Do: · We are currently searching for a Clinical Research Coordinator to provide clinical research coordination and protocol navigation ...
-
Research Coordinator II
1 week ago
Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Research Coordinator II to support research studies focused on pain at the Uniformed Services University (USU) and Walter Reed National Military Center (WRNMMC). · This position will be in support of the Defense & Veterans Center fo ...
-
Research Coordinator II
1 week ago
Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Research Coordinator II to write, edit, document, and package protocols, consent forms and other regulatory documents for all assigned medical centers. Specifically, responsible for study start-up activities and regulatory managemen ...
-
Clinical Research Coordinator
2 weeks ago
GAP Solutions, Inc. (GAPSI) Bethesda, United StatesPosition Objective: Provide services as a Clinical Research Coordinator in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). The primary role for this Research Coordinator (RC) ...
-
Clinical Research Coordinator
1 week ago
Kelly Bethesda, United StatesThe National Institutes of Health is seeking a Clinical Research Coordinator. This is a long-term, full-time, contract position based in Bethesda, MD. This is an on-site position. This position offers a competitive benefits package. · PRIMARY RESPONSIBILITIES: · This position inv ...
-
Clinical Research Coordinator
6 days ago
Axle Bethesda, United StatesJob Description · Job Description: · Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With expe ...
-
Clinical Research Coordinator
2 weeks ago
GAP Solutions, Inc. (GAPSI) Bethesda, United StatesProvide services as a Clinical Research Coordinator in support of the overall functions of the National Institute of Neurological Disorders and Stroke (NINDS) within the National Institutes of Health (NIH). The primary role for this Research Coordina Clinical Research, Research C ...
-
Clinical Research Coordinator
1 week ago
22nd Century Healthcare Bethesda, United StatesJob Title: Clinical Research Coordinator · Location: Bethesda MD 20814 · Duration: 3 Years to Permanent · Shift: 40 Hours/Week (Mon to Fri) · Teleworking Eligible: Yes · Onsite: Yes · Position Requirements · Overall Position Summary and Objectives · The primary role for this ...
-
Clinical Research Coordinator
2 weeks ago
Columbus Technologies Bethesda, United StatesOverview: · Must be a US Citizen or Green Card Holder · W2 with full benefit · Some travel may be required · Offer contingent on ability to successfully pass a background check and drug screen · Eligible for some Telework · Columbus Technologies and Services Inc. is a strat ...
-
Clinical Research Coordinator II
1 week ago
Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Clinical Research Coordinator II to perform clinical research and patient treatment in conjunction with one or more specified clinical research protocols. Supervised by either a Clinical Site Manager or designee. · This position wil ...
-
Clinical Research Coordinator I
1 week ago
Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Clinical Research Coordinator I to perform clinical research and patient treatment in conjunction with one or more specified clinical research protocols. Supervised by either a Clinical Site Manager or designee. · This position will ...
-
Clinical Research Coordinator II
1 week ago
Henry M. Jackson Foundation Bethesda, United StatesOverview · Join the HJF Team · HJF is seeking a Clinical Research Coordinator II to perform clinical research and patient treatment in conjunction with one or more specified clinical research protocols. Supervised by either a Clinical Site Manager or designee. This is a project-b ...
-
Clinical Research Coordinator II
6 days ago
Henry M. Jackson Foundation for the Advancement of Military Medicine Bethesda, United States Full timeJoin the HJF TeamThe Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent s ...
-
Research Coordinator
4 days ago
AHRI Arlington, United StatesJob Description · Job DescriptionEnsuring human comfort, productivity, and safety, while practicing environmental stewardship is the mission of the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). Our 300+ member companies produce more than 90 percent of the residen ...
Research Coordinator I - Bethesda, United States - Henry M. Jackson Foundation
Description
OverviewJoin the HJF Team
HJF is seeking a Research Coordinator I to write, edit, document, and package protocols, consent norms and other regulatory documents for all assigned medical centers.
Responsible for protocols from all sponsors (federal and non-federal) and completing all actions in order for the protocol to receive final IRB Approval.
The John P. Murtha Cancer Center at Walter Reed Bethesda is a modern, patient-centric, tri-service military health care facility.Its comprehensive core of military and civilian oncologists and other cancer-trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services.
Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies.
This position will be in support of The Uniformed Services University of the Health Sciences, The Center for Military Precision Health, The American Genome Center, and the Applied Proteogenomics Organizational, Learning and Outcomes (APOLLO) Network.
Note:
This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine.We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.
HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
ResponsibilitiesEducation and Experience
Security Requirements:
Ability to obtain and maintain a T Public Trust Investigation.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.?
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
#J-18808-Ljbffr