Position Information:

Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute on Drug Abuse. The primary objective is to provide services and deliverables through performance of support services.

Additional Qualifications

Certifications & Licenses:

• Minimum of one (1) year of experience in behavioral counseling, preferably in drug/smoking/alcohol treatment.

• Minimum of three (3) years of experience in a research related field.

• Master’s degree in psychology, social work, biological sciences or related discipline.

• Basic Life Support (BLS) certification will be required – training will be provided.

Field of Study:

• Social Work (Required)

Software:

• Proficient computer skills required (e.g. Microsoft Office)

Skills:

• Will complete all NIH/NIDA Mandatory trainings or/and other required trainings by the deadline set forth.

• Excellent analytical, organizational and time management skills required.

• Strong communications skills, both oral and written.

• Exceptional interpersonal skills, customer service oriented and client focused approach to work due to extensive participant contact.

• Previous experience in human subjects’ interaction (clinical or research).

• Previous clinical trial work

Deliverables:

• Work products and documents related to administering mental health assessments and diagnostic interviews. - Ad-Hoc

• Work products and documents related to obtaining participant medical and drug use information according to protocol criteria. - Ad-Hoc

• Work products and documents related to obtaining informed consent documentation from participants in the screening protocol. - Ad-Hoc

• Work products and documents related to follow-up correspondence to candidates on recruiting status. - Ad-Hoc

• Work products and documents related to arranging travel and distributing remuneration for candidates. - Ad-Hoc

• Work products and documents related to scheduling phone screen scripts, in person screening appointments and communications with candidates. - Ad-Hoc

• Work products and documents related to data entry in the electronic medical record system., generating reports; perform study procedures; process and destroy specimens as needed; maintain storage records/inventory of biological specimens. - Ad-Hoc

Statement of Work Details:

• Assist preparing and submitting for review accurate source documents related to all research procedures . - 1
• Participate in developing and maintaining research protocol documentation and operations. - 2
• Assist researchers with study testing, observations data entry and other duties associated with study sessions. - 3

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Acquaint participants with the MRI or mock MRI scanner to assess their comfort level, fit and eligibility to participate in MRI studies.

• Collects research data and prepares information for inputs and analysis.

• Verify study participant information and collect data and results of testing.

• Assist staff develop, assemble related documentation and maintain regulatory binders for all protocols.

• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.

• Set up, format and enter data into spreadsheets to analyze information and create reports.

• Enter data into research databases, systems and applications for ongoing studies.

• Supports the development of forms and questionnaires.

• Assist researchers develop, maintain and complete study data collection forms and source documents.

• Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.

• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes summaries.

• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.

• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.

• Assist researchers with the collection and analysis of research data and samples.

• Monitors subject's progress and reports adverse events.

• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.

• Supports assembly, development and review of new research projects.

• Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.

• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.

• Assist researchers develop and maintain current and new research protocols.

• Supports the creation and management of clinical websites and web-based tools.

• Collaborate with information technology IT staff to perform updates to a variety of websites.

• Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Maintain and organize an online resource of documentation regarding clinical trials, including Standard Operating Procedure documents for all tasks related to the handling of clinical trials.

• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Prepare and submit for review accurate source documents related to all research procedures.

• Develop and maintain research protocol documentation and operations.

• Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

• Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.

• Organize, prepare and distribute informational materials and provide support to the educational mission of the study.

• Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.

• Mentor new clinical research coordinators on all aspects of research support.