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Clinical Research Advisor
1 month ago
Location : IC: NIMH Street: 6001 Executive Blvd. Bldg.: NSC Room: 6116 City: Rockville State & Zip: MD 20892
Weekly Hours - FT: 30-40 hours per week Total No. of Hours : 40
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)
Min Education - Master's
Resume Max Pages - 3
Certifications & Licenses
- Certified Clinical Research Associate (CCRA)
- Ph.D. in a related discipline; three (3) years of specialized experience plus a Master's degree is equivalent to a Ph.D.; five (5) years of specialized experience plus a Bachelor's degree is equivalent to a Ph.D.
Skills (Ranked By Priority)
- Identifying, evaluating and establishing clinical trial sites
- Training clinical trial site staff
- Minimum of nine (9) years of experience conducting and monitoring clinical research studies
1, 2, 3, 4, 5 represent priority rankings, where 1 is the highest priority and 5 is the lowest priority of those ranked
Software
- Microsoft Office Suite
Field of Study
- Neuroscience
Statement of Work Details
Other
- 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 Centres 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 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 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.
- Provide recommendations to CTOBB 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; 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.
Reviews, assesses and evaluates clinical trial design and feasibility.
- 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 Centres 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. 5
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
