Clinical Research Specialist

2 weeks ago

Rockville, Maryland, United States Guidehouse Full time

Job Family:
Clinical Trial Operations (Digital)

Travel Required:
None

Clearance Required:
Ability to Obtain Public Trust

Role Overview:
We are seeking a Clinical Research Specialist to provide essential support services that align with the operational goals of the National Institute of Mental Health (NIMH). This position is a full-time opportunity.

In this role, you will collaborate effectively with Clinical Trials Operations and Biostatistics (CTOBB) personnel, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs), and Institute Contracting Officers. You will offer guidance to CTOBB based on your observations of activities at Clinical Trials Coordinating Centers and clinical sites.

Your responsibilities will include implementing the Clinical, Research, Support, Education, and Training (CREST) initiatives for designated research projects. You will work alongside CTOBB staff to establish a unique monitoring program for NIMH-funded studies.

Conducting routine and for-cause observation visits will be part of your duties, as well as managing the prequalification, qualification, initiation, organization, and closeout processes. Regular reviews of study data will be performed in accordance with monitoring guidelines.

Additionally, you will prepare reports from observation visits, ensuring timely submission and follow-up on audit findings and corrective action plans. You will assess and recommend appropriate follow-up actions for issues at clinical sites, including documentation deficiencies and training needs.

Your expertise will be crucial in advising on guidelines and standards for clinical trial conduct to guarantee data quality and adherence to regulatory requirements. You will provide feedback on study documents such as monitoring plans, procedures manuals, protocols, and informed consent forms.

Maintaining up-to-date knowledge of FDA regulations, Good Clinical Practice (GCP), NIH policies, and human subject regulations is essential. You will demonstrate proficiency in data management systems and remote data monitoring.

Staying informed about regulatory monitoring literature and the design and execution of scientific studies is expected. You will interpret and recommend applications of monitoring guidelines and track their implementation effects.

Developing suggested SOPs/Guidelines and templates to enhance operational and monitoring oversight of clinical trials will be part of your role. You will serve as a key contact for policies, procedures, and regulations relevant to research methodologies.


Qualifications:

PhD OR a Master's degree with a minimum of THREE (3) years of specialized experience OR a Bachelor's degree with at least FIVE (5) years of specialized experience equivalent to a PhD.

A minimum of FIVE (5) years of experience in conducting and monitoring clinical research studies is required, along with experience in identifying and evaluating clinical trial sites and training site staff.

Proficiency in Microsoft Office Suite is necessary.


Preferred Qualifications:
Certification as a Clinical Research Associate (CCRA) is preferred. Previous experience with the National Institute of Health (NIH) is also desirable.

What We Offer:
Guidehouse provides a comprehensive rewards package that includes competitive compensation and a flexible benefits plan 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.

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.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with applicable law. If you require an accommodation, please contact Guidehouse Recruiting.

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