Clinical Research Specialist

2 weeks ago

Rockville, Maryland, United States Guidehouse Full time

Job Family:

Clinical Trial Operations (Digital)


Travel Requirements:

No travel required


Security Clearance:

Ability to Obtain Public Trust

Position Overview:
We are seeking a Clinical Research Advisor to provide independent support services aimed at achieving the operational goals of the National Institute of Mental Health (NIMH). This is a full-time role.

  • Collaborate effectively with Clinical Trials Operations and Biostatistics (CTOBB) personnel, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs), and Institute Contracting Officers; offer guidance to CTOBB based on observations of activities at Clinical Trials Coordinating Centers and clinical sites.
  • Execute the Clinical, Research, Support, Education, and Training (CREST) initiatives for designated research projects.
  • Partner with CTOBB staff to create an innovative monitoring framework for NIMH-funded studies.
  • Conduct regular and cause-specific observation visits; manage the prequalification, qualification, initiation, organization, and closure processes.
  • Perform systematic reviews of study data in accordance with monitoring guidelines.
  • Generate reports on observation visit funding; ensure prompt submission of reports and follow-up actions in response to audit findings.
  • Identify and recommend appropriate follow-up actions for issues at clinical sites, including documentation deficiencies, communication gaps, and additional training needs.
  • Provide advice on guidelines and standards for conducting clinical trials to ensure data integrity and compliance with regulatory standards.
  • Offer feedback to CTOBB staff on study documents such as monitoring plans, procedures manuals, protocols, and informed consent forms.
  • Stay updated on FDA regulations, Good Clinical Practice (GCP), NIH policies, and human subject regulations.
  • Exhibit proficiency in data management systems and remote data monitoring.
  • Keep abreast of regulatory monitoring literature and the design and execution of scientific studies; engage in literature review, meetings, conferences, and workshops.
  • Analyze and provide recommendations on the application of monitoring guidelines; monitor the impact of their implementation.
  • Develop suggested Standard Operating Procedures (SOPs), guidelines, and templates to enhance operational and monitoring oversight of clinical trials.
  • Act as the primary contact for policies, procedures, rules, and regulations related to relevant research methodologies.

Qualifications:

  • PhD or a Master's degree with three (3) years of specialized experience, or a Bachelor's degree with five (5) years of specialized experience equivalent to a PhD.
  • At least five (5) years of experience in conducting and monitoring clinical research studies.
  • Experience in identifying, evaluating, and establishing clinical trial sites.
  • Experience in training clinical trial site personnel.
  • Proficiency in Microsoft Office Suite.

Preferred Qualifications:

  • Certification as a Clinical Research Associate (CCRA) is preferred.
  • Prior experience with the National Institutes of Health (NIH) is advantageous.

What We Offer:

Guidehouse provides a comprehensive rewards package that includes competitive compensation and a flexible benefits package, reflecting our commitment to fostering 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 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.

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