Clinical Protocol Coordinator

Job Family:

Clinical Trial Operations (Digital)

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

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:

• 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.

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).

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.

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

• 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

About Guidehouse

Guidehouse is an Equal Opportunity Employer–Protected 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 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. 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 @guidehouse.com or guidehouse@myworkday.com.  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 Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s 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.