Posted on: May 26, 2023
Job Family:Clinical Trial Operations (Digital)Travel
Required:NoneClearance Required:Ability to Obtain NACIWhat You Will
- Assist Principal Investigators (PI) with the writing/revising
of existing and new clinical research protocols, informed consent
forms (ICFs), and other study documents by completing standard
wording for regulatory sections as well as reviewing / revising
other sections of documents for consistency.
- Format documents.
- Ensure consistency within protocol and between protocol and
- Maintain proper and consistent communication with PIs /
research teams by attending regular study/team meetings or calls to
stay on track of development of study documents.
- Distribute appropriate forms for PI, Peer Reviewers and Branch
- Assist PIs in incorporating suggested changes and respond to
- Collecting all forms and PI responses to prepare a Branch
- Prepare new submissions for Ancillary Review and IRB
- Prepare periodic submissions to Ancillary Review
- Manage completion of Resource Assessment Forms (PRIA), Travel
Reimbursement Forms (DRTS), Ethics Clearance submissions (DEC) and
Radiation Safety Committee submission (RSC) (when applicable). Also
respond to OPS (Office of protocol Service) Protrak requests.
- Assist with submitting requests for Recruitment Flyers and
collaborate with Office of Recruitment for the development
- Prepare and submit continuing reviews (with assistance of
research team and data managers), protocol amendments, various
other IRB submissions in consultation with PI.
- Maintain Regulatory Binder.
- Update Protocol View.
- Keep up with IRB and ORSC Policies and SOPs.
- Facilitate interactions with FDA Regulatory Managers (when
- Assist in responding to stipulations (when applicable).
- Assist with preparing and submitting materials for Annual and
Quadrennial Scientific review submissions.
- Assist with Reliance Agreement requests and submissions.
- Coordinate translations of consents as needed.
- Assist research team with monitoring visits in regard to the
- Act and liaison and main Point of Contact between IRB, sponsor
and other sites.
- Proactively participate in the peer review process and utilize
the systems for tracking, management and storage of documents and
- Be flexible and agile shifting priorities in supporting
research teams.What You Will Need:
- BS degree in Biomedical Sciences or related discipline
- Experience writing and reviewing protocols
- Experience managing multiple project and timelines
- Strong written and verbal communication skills
- Experience managing IRB submissions desired, but not
requiredThe annual salary range for this position is
$89,100.00-$133,700.00. Compensation decisions depend on a wide
range of factors, including but not limited to skill sets,
experience and training, security clearances, licensure and
certifications, and other business and organizational needs.What We
Offer:Guidehouse offers a comprehensive, total rewards package that
includes competitive compensation and a flexible benefits package
that reflects our commitment to creating a diverse and supportive
- Medical, Rx, Dental & Vision Insurance
- Personal and Family Sick Time & Company Paid Holidays
- Parental Leave
- 401(k) Retirement Plan
- Group Term Life and Travel Assistance
- Voluntary Life and AD&D Insurance
- Health Savings Account, Health Care & Dependent Care Flexible
- Transit and Parking Commuter Benefits
- Short-Term & Long-Term Disability
- Tuition Reimbursement, Personal Development, Certifications &
- Employee Referral Program
- Corporate Sponsored Events & Community Outreach
- annual membership
- Employee Assistance Program
- Supplemental Benefits via Corestream (Critical Care, Hospital
Indemnity, Accident Insurance, Legal Assistance and ID theft
- Position may be eligible for a discretionary variable incentive
bonusAbout GuidehouseGuidehouse is an Equal Employment Opportunity
/ Affirmative Action employer. All qualified applicants will
receive consideration for employment without regard to race, color,
national origin, ancestry, citizenship status, military status,
protected veteran status, religion, creed, physical or mental
disability, medical condition, marital status, sex, sexual
orientation, gender, gender identity or expression, age, genetic
information, or any other basis protected by law, ordinance, or
regulation.Guidehouse will consider for employment qualified
applicants with criminal histories in a manner consistent with the
requirements of applicable law or ordinance including the Fair
Chance Ordinance of Los Angeles and San Francisco.If you have
visited our website for information about employment opportunities,
or to apply for a position, and you require an accommodation,
please contact Guidehouse Recruiting at 1- or via email at . All
information you provide will be kept confidential and will be used
only to the extent required to provide needed reasonable
accommodation. Guidehouse does not accept unsolicited resumes
through or from search firms or staffing agencies. All unsolicited
resumes will be considered the property of Guidehouse and
Guidehouse will not be obligated to pay a placement fee.
Keywords: Guidehouse, Bethesda , Protocol Navigator, Other , Bethesda, Maryland
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