Clinical Protocol Coordinator

Job Family:

Travel Required:

Clearance Required:

What You Will Do:
We are currently searching for a 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.

• 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.

#SOAR

What You Will Need:

• Masters Degree OR Bachelors Degree PLUS TWO (2) years of related experience is equivalent to a Masters 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.

What Would Be 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).

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 bonus

About Guidehouse

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.

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.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @ or . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse please report the matter to Guidehouses Ethics Hotline. If you want to check the validity of correspondence you have received please contact . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicants dealings with unauthorized third parties.

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.