Job description

Overall Position Summary and Objectives

Contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH)

Qualifications Certifications & Licenses -

• Senior CRA; Minimum of nine (9) years of experience conducting and monitoring clinical research studies. -
• CCRA (Certified Clinical Research Associate). -
• Completion of the Barnett International 30-Hour Clinical Research Auditing Certification Program within 6 months of hire. - -
• Ph.D. in a related discipline preferred.

Field of Study -

• Neuroscience

Software -

• Expertise in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint).

Skills -

• SOPs -
• Identifying, evaluating and establishing clinical trial sites -
• Clinical Trials -
• Current knowledge of FDA regulations, Good Clinical Practices (GCP), NIH policies, and human subject regulations. -
• Strong communications skills, both oral and written. -
• Excellent analytical, organizational and time management skills. -
• Keeping abreast of current literature.

Statement of Work Details

Conduct routine and for cause observation visits; conduct over 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. Review protocols and informed consent forms of clinical trials sponsored prior to their implementation to provide comments to appropriate CTOBB staff. Maintain current knowledge of FDA regulations, Good Clinical Practices (GCP), NIH policies and human subject regulations. 3 | Page Demonstrate expertize in data management systems and remote data monitoring. Provide feedback to CTOBB staff regarding informed consent, clinical exemption, NIH policy and regulatory requirements and NIH oversight requirements. Provide recommendations to CTOBB in the ongoing technical decision making required to facilitate optimal progress of the trials. Provide recommendations on promoting the most effective and efficient operation of assigned and potential research program activities based on scientific knowledge of state of-the-art research technology. Collaborate with staff on the design and implementation of scientific studies; read current literature; participate in meetings, conferences and workshops. Interpret and provide advice on the application of monitoring guidelines; track the effects of implementation on the field. Develop recommended SOPs/Guidelines and templates to facilitate the operational and monitoring oversight of clinical trials. Provide expertise advice related to clinical trial monitoring and good clinical practice; serve as branch point of contact on policies, procedures, rules and regulations concerning programmatically relevant research methods and approaches. Work closely with Clinical Trials Operations and Biostatistics (CTOBB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs) and Institute Contracting Officer; advise CTOBB regarding the need for on-site monitoring of activities of both the Clinical Trials Coordinating Centers and/or the Clinical sites. Organize and coordinate the risk-based audit/monitoring process of research studies. Reviews, assesses and evaluates clinical trial design and feasibility. Work collaboratively with Clinical Trials Operations (CTOB) staff, Principal Investigators (PIs), Clinical Coordinators, Government Project Officers (GPOs) and Institute Contracting Officers; advise regarding the findings of on-site observation of activities of both the Clinical Trials Coordinating Centers and/or the Clinical sites. 1 Develop and implement the Clinical, Research, Support, Education and Training (CREST) activities for identified research studies. 2 Collaborate with CTOB staff to develop a non-traditional site monitoring-based education program for NIMH funded studies. 3 Conduct on-site observation visits. 4 Perform reviews of study data according to data review/monitoring guidelines. 5 Develop reports of observation visit findings; ensure timely submission of reports and follow-up in response to 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 to ensure data quality and compliance with regulatory requirements for clinical research. 4 | Page Provide feedback to OCR 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. Provide recommendations to CTOB in the ongoing technical decision making required to facilitate optimal progress of the trials. 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 branch point of contact on policies, procedures, rules and regulations concerning programmatically relevant research methods and approaches. Reviews, evaluates and analyzes clinical trial data and study information. N/A Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation. N/A Assesses and supports meetings, clinical trial assessments and site visits. N/A Formulates guiding principles and Standard Operating Procedures (SOPs), and prepares staff for clinical research. N/A Reviews, assesses and evaluates clinical trial design and feasibility. N/A Reviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementation. N/A Deliverables Work products and documents related to working with staff and advising on the findings of on-site observation of activities; implementing CREST activities for identified research studies; developing a non-traditional monitoring and education program for NIMH funded studies. - Ad-Hoc Work products and documents related to conducting observation visits; performing regular reviews of study data; developing reports on observations of visit funding; ascertaining and recommending responses to issues at clinical sites. - Ad-Hoc Work products and documents related to developing recommended guidelines and standards for conduct of clinical trials; reviewing protocols and informed consent forms; performing data management and remote data monitoring. - Ad-Hoc Work products and documents related to providing ongoing technical advice and education to facilitate optimal progress of trials; providing recommendations to scientists and researchers; designing and implementing scientific studies; participating in meetings. - Ad-Hoc Work products and documents related to interpreting and providing advice and education on the application of monitoring guidelines; tracking effects of implementation; developing recommended SOPs, guidelines and templates. - Ad-Hoc

Job Type: Full-time

Pay: $115,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• Will you require employer sponsorship to work in the US?
• The salary range for this position is $115K-$175K/yearly based on years of experience. What is your desired salary range?

Education:

• Master's (Preferred)

Experience:

• conducting and monitoring clinical research studies: 9 years (Preferred)

License/Certification:

• CCRA (Preferred)

Work Location: In person

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