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 Advisor. This role will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH). This is a full-time opportunity located in Rockville, MD.

• Work collaboratively with Clinical Trials Operations and Biostatistics (CTOBB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs) and Institute Contracting Officers; advise CTOBB regarding 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.

• Collaborate with CTOBB staff to develop a non-traditional monitoring program for NIMH funded studies.

• Conduct routine and for cause observation visits; conduct the prequalification, qualification, initiation, organization, and closeout process.

• Perform regular reviews of study data according to data review/monitoring guidelines.

• Develop reports of observation visit funding; ensure timely submission of reports and follow-up responses/corrective action plans in response to audit findings.

• Ascertain and recommend appropriate follow-up response 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 in order 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; participating 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 branch point of contact on policies, procedures, rules and regulations concerning programmatically relevant research methods and approaches.

#SOAR

What You Will Need :

• 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

What Would Be Nice To Have :

• 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

• 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.