Position Objective: The Clinical Advisor will provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH) within the National Institutes of Health.
Duties and Responsibilities:
- Assists researchers develop clinical trial protocols, including objectives, design, methodology, statistical considerations and organization of the study.
- Develops and delivers recommendations and changes to clinical trial protocols to improve the overall effectiveness of the study.
- Review protocol and consent changes, as well as other implementation and operations procedures as necessary.
- Assist researchers implement and monitor clinical trials, collecting data and preparing project updates, status reports and summaries of results.
- Assist researchers develop project schedules, quality assurance plans and budgets in accordance with stakeholder expectations.
- Organize and coordinate the risk-based audit/monitoring process of research studies.
- 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.
- 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. 1
- Reviews, evaluates and analyzes clinical trial data and study information.
- Gather, interpret, synthesize, and analyze clinical trial data for inclusion in a variety of documents and reports.
- Create data collection plans and provide regular written reports detailing progress against tasks and milestones.
- Provide periodic progress reports that include updated status and progress on the contracted tasks.
- Organize and coordinate the risk-based audit/monitoring process of research studies. Conduct routine and for cause observation visits; conduct over the prequalification, qualification, initiation, organization and closeout process. 2
- Perform regular reviews of study data according to data review/monitoring guidelines. 4
- Develop reports of observation visit funding; ensure timely submission of reports and follow-up responses/corrective action plans in response to audit findings. 5
- Conduct routine and for cause observation visits; conduct over the prequalification, qualification, initiation, organization and closeout process. 3
- Provide expert advice to the staff regarding project management support to clinical relevance and clinical data analysis trials, including scheduling, resource and budget management and reporting. Provide scientific and administrative project management support.
- Identify and monitor clinical trial risks. Manage project risk by proactively anticipating issues and develop contingency plans and solutions.
- Assesses and supports meetings, clinical trial assessments and site visits.
- Attend and participate in specific meetings related to clinical trials and assist researchers gather information and report status.
- Attend site initiation visits, site qualifying visits and protocol start-up meetings to gather information and make recommendations.
- Research and recommend processes and workflows for managing requests for materials.
- Research and write standard operating procedures (SOP) for clinics and clinical trials.
- Review industry best practices, procedures and policies associated with clinical trials and recommend areas for improvement.
- Reviews, assesses and evaluates clinical trial design and feasibility.
- Develop project schedules, quality assurance plans and budgets in accordance with stakeholder expectations.
- Develop frequently asked questions and other informational and guidance documents.
- Provide project management advice and recommendations to clinical trials, including scheduling, resource and budget management and Reporting
- Work products and documents related to providing recommendations and coordinating risk-based audit and monitoring process of research studies; conducting routine and for cause observation of activities; performing regular reviews of study data; ascertaining and recommending follow-up response to issues.
- 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.
- Work products and documents related to providing ongoing technical advice to facilitate optimal progress of trials; providing recommendations to scientists and researchers; designing and implementing scientific studies; participating in meetings.
- Work products and documents related to interpreting and providing advice on the application of monitoring guidelines; tracking effects of implementation; developing recommended SOPs, guidelines and templates
Basic Qualifications:
- Master's degree in Nursing Education, Neuroscience, or a related field
- 8 years experience
- Skilled in Identifying, evaluating and establishing clinical trial sites, SOPs, and skilled in Clinical trials
Preferred Qualifications:
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
This position is contingent upon contract award.