Clinical Research Advisor

4 days ago

Rockville, Maryland, United States Guidehouse Full time

Job Summary:

Guidehouse is seeking a highly skilled Clinical Research Advisor to join our team. As a Clinical Research Advisor, you will play a critical role in supporting the operational objectives of the National Institute of Mental Health (NIMH). This is a full-time opportunity located in Rockville, MD.

Key Responsibilities:

  • Collaborate with Clinical Trials Operations and Biostatistics (CTOBB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs), and Institute Contracting Officers to advise on the findings of on-site observation of activities of both the Clinical Trials Coordinating Centers and/or the Clinical sites.
  • Implement the Clinical, Research, Support, Education, and Training (CREST) activities for identified research studies.
  • Develop a non-traditional monitoring program for NIMH-funded studies in collaboration with CTOBB staff.
  • Conduct routine and for-cause observation visits, including prequalification, qualification, initiation, organization, and closeout processes.
  • Perform regular reviews of study data according to data review/monitoring guidelines.
  • Develop reports of observation visit funding and ensure timely submission of reports and follow-up responses/corrective action plans in response to audit findings.
  • Ascertain and recommend appropriate follow-up responses to issues at clinical sites, including potential deficiencies in documentation, communication, and the need for additional training.
  • Advise on guidelines and standards for the conduct of clinical trials to ensure data quality and compliance with regulatory requirements for clinical research.
  • Provide feedback to CTOBB staff as requested on study documents, including monitoring plans, manuals of procedures, protocols, and informed consent forms.
  • Maintain current knowledge of FDA regulations, Good Clinical Practice (GCP), NIH policies, and human subject regulations.
  • Demonstrate expertise in data management systems and remote data monitoring.
  • Maintain current knowledge of regulatory monitoring literature as well as the design and implementation of scientific studies; read current literature; participate in meetings, conferences, and workshops.
  • Interpret and provide recommendations on the applications of monitoring guidelines; track the effects of implementation.
  • Develop recommended SOPs/Guidelines and templates to facilitate the operational and monitoring oversight of clinical trials.
  • Serve as a branch point of contact on policies, procedures, rules, and regulations concerning programmatically relevant research methods and approaches.

Requirements:

  • PhD or a Master's degree plus THREE (3) years of specialized experience OR Bachelor's degree plus FIVE (5) years of specialized experience is equivalent to Ph.D.
  • Minimum of FIVE (5) years of experience conducting and monitoring clinical research studies.
  • Experience in identifying, evaluating, and establishing clinical trial sites.
  • Training clinical trial site staff experience.
  • Proficient in Microsoft Office Suite.

Preferred Qualifications:

  • Certified Clinical Research Associate (CCRA) 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

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