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Clinical Research Protocol Specialist

2 months ago

Bethesda, Maryland, United States Guidehouse Full time

Job Family:
Clinical Trial Operations (Digital)

Travel Required:
None

Clearance Required:
Ability to Obtain Public Trust

Key Responsibilities:
We are seeking a Clinical Research Protocol Specialist to deliver regulatory support for clinical research through the NINDS Clinical Trials Unit (CTU) within the NINDS Intramural Research Program. This position focuses on the development of clinical research protocols and informed consent documents, necessitating exceptional writing capabilities. Responsibilities include managing Institutional Review Board (IRB) submissions and regulatory documentation, among other essential study tasks. This is a full-time, on-site role.


Key tasks include:

  • Developing and reviewing new and amended clinical research protocols and associated documentation throughout the study lifecycle, ensuring accuracy, consistency, and completeness.
  • Utilizing Electronic Data Capture Systems and Electronic Medical Records Systems (EMR).
  • Employing Clinical Trial Management Systems (CTMS) and demonstrating strong writing skills in clinical research protocol development.
  • Conducting on-site visits, IRB submissions, and ensuring clinical research and data integrity.
  • Training clinical trial site personnel and liaising with regulatory authorities.
  • Holding certifications from recognized clinical research organizations.

Preferred Qualifications:
Desirable areas of study include nursing, biology, general science, or health services. Familiarity with electronic medical record systems and prior clinical trial experience is advantageous. A minimum of 3 years of relevant experience is required.

Essential Requirements:
A Master's Degree is necessary. Responsibilities also include developing training plans and instructing staff on proper protocol submission techniques. The role involves reviewing and maintaining trial-related documents and operational procedures, as well as collecting, distributing, filing, and submitting regulatory documents.


Additional duties encompass:

  • Reviewing clinical research protocols and related documentation during the developmental phase and prior to submission, recommending changes as necessary.
  • Collaborating with the NINDS Clinical Trials Unit (CTU) and NINDS staff to develop standard operating procedures (SOPs) related to protocol navigation and regulatory writing.
  • Assisting researchers in collecting, distributing, and filing regulatory documents.
  • Maintaining study databases and conducting basic analyses.
  • Supporting researchers with protocol development, assembly, maintenance, and review of clinical trial documents and operational procedures.
  • Ensuring all regulatory trial documentation is complete and up-to-date, including maintaining a comprehensive Regulatory Binder for each trial.


We offer a comprehensive total rewards package that includes competitive compensation and a flexible benefits package reflecting our commitment to 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 Membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance, etc.)


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.