Protocol Navigator

Company: Guidehouse
Location: Bethesda
Posted on: May 26, 2023

Job Description:

Job Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain NACIWhat You Will Do:

• 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 ICF.
• 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 Chiefs.
• Assist PIs in incorporating suggested changes and respond to reviewers' comments.
• Collecting all forms and PI responses to prepare a Branch Review packet.
• Prepare new submissions for Ancillary Review and IRB committees.
• Prepare periodic submissions to Ancillary Review Committees.
• 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 materials.
• 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 applicable).
• 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 regulatory binder.
• 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 tasks.
• 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 workplace.Benefits include:
    • 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 Spending Accounts
    • Transit and Parking Commuter Benefits
    • Short-Term & Long-Term Disability
    • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
    • 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 protection, etc.)
    • 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