Guidehouse
Clinical Research Coordinator
This position will provide clinical protocol and human subjects safety support and expertise to researchers and research support staff in the NIH, NINDS, Stroke Branch. This is a full-time, on-site opportunity in Bethesda, MD. Responsibilities include: Write and edit study protocols, and amendments, reviews, reports, and other necessary forms. Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies. Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence. Coordinate with IRB administrator to collect, review and maintain all IRB records. Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure. Requirements include: Master's Degree OR Bachelor's Degree PLUS TWO (2) years of related experience is equivalent to a Master's Degree. A minimum of ONE (1) year of experience in Neuroscience or Clinical setting. Experience with implementation of clinical trial site action plans. Able to provide support and expertise in clinical protocol development. Previous protocol presentation to steering committees. Have liaising experience with regulatory authorities. Training clinical trial site staff. Coordinating project meetings. Proficiency in Electronic Data Capture Systems. Nice to have: Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), and/or Clinical Research Associate (CRA) preferred. Previous experience with the National Institute of Health (NIH). The annual salary range for this position is $65,000.00-$108,000.00. 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. 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. 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 Care.com 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 bonus Guidehouse is an Equal Opportunity EmployerProtected Veterans, Individuals with Disabilities 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.
This position will provide clinical protocol and human subjects safety support and expertise to researchers and research support staff in the NIH, NINDS, Stroke Branch. This is a full-time, on-site opportunity in Bethesda, MD. Responsibilities include: Write and edit study protocols, and amendments, reviews, reports, and other necessary forms. Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports. Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies. Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence. Coordinate with IRB administrator to collect, review and maintain all IRB records. Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure. Requirements include: Master's Degree OR Bachelor's Degree PLUS TWO (2) years of related experience is equivalent to a Master's Degree. A minimum of ONE (1) year of experience in Neuroscience or Clinical setting. Experience with implementation of clinical trial site action plans. Able to provide support and expertise in clinical protocol development. Previous protocol presentation to steering committees. Have liaising experience with regulatory authorities. Training clinical trial site staff. Coordinating project meetings. Proficiency in Electronic Data Capture Systems. Nice to have: Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), and/or Clinical Research Associate (CRA) preferred. Previous experience with the National Institute of Health (NIH). The annual salary range for this position is $65,000.00-$108,000.00. 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. 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. 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 Care.com 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 bonus Guidehouse is an Equal Opportunity EmployerProtected Veterans, Individuals with Disabilities 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.