Clinical Protocol Coordinator

Job Family:

Travel Required:

Clearance Required:

What You Will Do:

We are currently searching for Clinical Protocol Coordinator to provide support services to satisfy the overall operational objectives of the National Institute on Aging (NIA). The primary objective is to provide services and deliverables through performance of support services.  This is a full-time, on-site opportunity in Baltimore, MD.  

• Interact with NIA Principal Investigators (PI) and Institutional Review Board (IRB) staff to coordinate amendments, annual reviews, triennial reviews, terminations, adverse events, and other IRB interactions.
• Facilitate communication with IRB and NIH Clinical Center for protocol approval.
• Serve a central point of contact for NIA clinical research protocol activity.
• Organize/coordinate quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals, and others.
• Schedule monthly NIA Clinical Investigators’ and Scientific Review Committee meetings.
• Coordinate/schedule protocol initiation meeting with appropriate staff, facilitate protocol updates, amendments and other documents as needed to obtain IRB approval.
• Assist researchers develop protocol documentation including schemas, patient calendars, and teaching aids; assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
• Maintain accurate records of all protocols and study applications, safety reports, annual reports, and correspondence.
• Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• 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.
• Manage, track, and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.

What You Will Need:

• Bachelor’s degree or Associate degree and plus TWO (2) years of additional experience.
• Minimum of FIVE (5) years of experience coordinating clinical trial related activities
• Familiar with Institutional Review Board (IRB) requirements and submissions
• Possess knowledge of clinical protocols, medical terminology, and navigating protocols

What Would Be Nice To Have:

• Holding a Certified Clinical Research Professional (CCRP) certification highly desired
• Strong communications skills, both oral and written
• Liaise with regulatory authorities and ethics committee(s)
• Coordinate project meetings
• Maintain regulatory compliance
• Scheduling
• SOPs
• Excellent organizational, interpersonal and time management skills

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 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 1-571-633-1711 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.

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.