Clinical Research Associate
About the Role:
Clinical Research Associate supporting the Traumatic Brain Injury Center of Excellence's (TBICoE) mission in Silver Spring, MD.
This position is in direct support of the TBICoE clinical research mission.
Clinical Research Associate is responsible for assisting with all activities associated with conducting clinical research investigations and/ or human subject research.
Clinical Research Associate will plan, conduct and complete clinical research investigations under the supervision of the lead of the project.
Clinical Research Associate will participate in all aspects of research including recruitment, informed consent, data collection, organization, literature reviews, structured interviews, analysis and interpretation of basic data and will assist with the preparation of technical reports, summaries and protocols.
Clinical Research Associate will ensure compliance with local, state, and/or federal regulatory requirements.
Primary
Responsibilities:
Engages in all aspects of research execution, including screening, recruitment, obtaining informed consent, data collection via participant interview (in person or teleweb) or structured interview or cognitive- behavioral testing, medical record review, scheduling, quality control / quality assurance activities and regulatory activities.
Assists the Principal/ Associate Investigators in the preparation and submission of clinical protocols, consent forms and other documents to the scientific review committee, IRB and other regulatory organizations and SOPs Assists the development of study manuals.
Maintains regulatory files for TBICoE clinical investigations.
Communicates with research participants, staff, regulatory affairs and data management groups, laboratory technicians and clinical investigators, management and outside collaborators.
Recruits, interviews, and screens TBICoE clinical research study volunteers, administers and obtains informed consent.
Assists in the collection and analysis of data to evaluate volunteer eligibility for enrollment.
Assists in the collection and analysis of laboratory and clinical data obtained during a medical evaluation, reports significant values, findings and events that require prompt attention to clinical investigators.
Assists with the documentation and reporting of adverse events, completes and reviews study forms for potential research subject eligibility, protocol compliance, omissions, and errors and submits these forms as required.
Prepares and maintains written and electronic volunteer databases/logs.
Performs data extraction and chart reviews of patients' and/or consented research participant medical records or other relevant records/ systems as applicable.
Reviews the source document file for information such as verification of critical variables, entrance criteria, date of visit and lab data.
Ensures that research records are stored and secured properly and that inventory and records are updated and properly maintained.
Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data in study forms (hardcopy and/or electronic).
Prepares documents, under direction of project leads.
Reports statistical analyses and descriptive data from research participant data to be used in research reports.
Plans, conducts and completes investigations under the supervision of the head of the project.
Participates in data collection and organization, literature reviews, structured interviews, provides basic data analysis and interpretation.
Assists with the preparation of technical reports, summaries and protocols.
Maintains clear and accurate records, inventories and logbooks.
Verifies and corrects data entry for research projects, supports senior staff in quality control.
Prepares requests for actions/proposals to include assisting with grant proposal applications, their associated documentations and requirements.
Facilitates the flow and approval processes for relevant projects as needed or requested.
Provides written updates to senior staff.
Position Requirements:
Knowledge, Skills and Abilities:
Excellent communication skills, organizational and analytical skills and proficiency in research conduct are required.
Knowledge of standard qualitative and quantitative data collection techniques; ability to follow general instructions; work in a team and supervise their research personnel assigned to protocols; excellent writing and analytical skills; familiarity with social science research methodology is required.
Ability to follow detailed instructions.
Must be able to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint.
Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
Minimum Education/Training Requirements:
Bachelor's Degree or higher in biology, psychology or related science required.
Master's Degree preferred.
Must have Human Subjects training completed.
Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.
Supervisory experience preferred.
Current certification in Basic Life support.
Must complete CITI/ HIPAA training.
Minimum
Experience:
2-4 years clinical investigation or human subject research experience required.
Prior experience within the DoD/VA systems of care preferred.
Physical Capabilities:
Must be able to sit and stand for long periods of time.
Must be able to carry light items - up to 25 lbs.
Supervisory Responsibilities/Controls:
Will supervise one or more assistants or junior colleagues.
Work Environment:
Office, clinical and hospital environment.
May encounter patients who are confused, agitated or abusive.
Must be available to travel locally, regionally, and nationally.
Office, clinical and hospital environment.
May include hours in the late afternoons, evenings, and/or weekends, depending on study assessments and participant scheduling requirements.
CITIZENSHIP AND CLEARANCE REQUIREMENTS:
Must be eligible to work in the US.
Must be able to pass a National Agency Check with Inquiries (NACI).
CICONIX, LLC is an Equal Opportunity Employer.
We E-Verify all employees.
Competitive market-based salary, commensurate with experience and education Comprehensive benefits available (Medical, Dental, PTO, 401k etc).
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Recommended Skills Analytical Assessments Basic Life Support Biology Clinical Research Clinical Research Coordination Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Research Associate supporting the Traumatic Brain Injury Center of Excellence's (TBICoE) mission in Silver Spring, MD.
This position is in direct support of the TBICoE clinical research mission.
Clinical Research Associate is responsible for assisting with all activities associated with conducting clinical research investigations and/ or human subject research.
Clinical Research Associate will plan, conduct and complete clinical research investigations under the supervision of the lead of the project.
Clinical Research Associate will participate in all aspects of research including recruitment, informed consent, data collection, organization, literature reviews, structured interviews, analysis and interpretation of basic data and will assist with the preparation of technical reports, summaries and protocols.
Clinical Research Associate will ensure compliance with local, state, and/or federal regulatory requirements.
Primary
Responsibilities:
Engages in all aspects of research execution, including screening, recruitment, obtaining informed consent, data collection via participant interview (in person or teleweb) or structured interview or cognitive- behavioral testing, medical record review, scheduling, quality control / quality assurance activities and regulatory activities.
Assists the Principal/ Associate Investigators in the preparation and submission of clinical protocols, consent forms and other documents to the scientific review committee, IRB and other regulatory organizations and SOPs Assists the development of study manuals.
Maintains regulatory files for TBICoE clinical investigations.
Communicates with research participants, staff, regulatory affairs and data management groups, laboratory technicians and clinical investigators, management and outside collaborators.
Recruits, interviews, and screens TBICoE clinical research study volunteers, administers and obtains informed consent.
Assists in the collection and analysis of data to evaluate volunteer eligibility for enrollment.
Assists in the collection and analysis of laboratory and clinical data obtained during a medical evaluation, reports significant values, findings and events that require prompt attention to clinical investigators.
Assists with the documentation and reporting of adverse events, completes and reviews study forms for potential research subject eligibility, protocol compliance, omissions, and errors and submits these forms as required.
Prepares and maintains written and electronic volunteer databases/logs.
Performs data extraction and chart reviews of patients' and/or consented research participant medical records or other relevant records/ systems as applicable.
Reviews the source document file for information such as verification of critical variables, entrance criteria, date of visit and lab data.
Ensures that research records are stored and secured properly and that inventory and records are updated and properly maintained.
Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data in study forms (hardcopy and/or electronic).
Prepares documents, under direction of project leads.
Reports statistical analyses and descriptive data from research participant data to be used in research reports.
Plans, conducts and completes investigations under the supervision of the head of the project.
Participates in data collection and organization, literature reviews, structured interviews, provides basic data analysis and interpretation.
Assists with the preparation of technical reports, summaries and protocols.
Maintains clear and accurate records, inventories and logbooks.
Verifies and corrects data entry for research projects, supports senior staff in quality control.
Prepares requests for actions/proposals to include assisting with grant proposal applications, their associated documentations and requirements.
Facilitates the flow and approval processes for relevant projects as needed or requested.
Provides written updates to senior staff.
Position Requirements:
Knowledge, Skills and Abilities:
Excellent communication skills, organizational and analytical skills and proficiency in research conduct are required.
Knowledge of standard qualitative and quantitative data collection techniques; ability to follow general instructions; work in a team and supervise their research personnel assigned to protocols; excellent writing and analytical skills; familiarity with social science research methodology is required.
Ability to follow detailed instructions.
Must be able to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint.
Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
Minimum Education/Training Requirements:
Bachelor's Degree or higher in biology, psychology or related science required.
Master's Degree preferred.
Must have Human Subjects training completed.
Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP) and/or Clinical Research Associate (CCRA) preferred.
Supervisory experience preferred.
Current certification in Basic Life support.
Must complete CITI/ HIPAA training.
Minimum
Experience:
2-4 years clinical investigation or human subject research experience required.
Prior experience within the DoD/VA systems of care preferred.
Physical Capabilities:
Must be able to sit and stand for long periods of time.
Must be able to carry light items - up to 25 lbs.
Supervisory Responsibilities/Controls:
Will supervise one or more assistants or junior colleagues.
Work Environment:
Office, clinical and hospital environment.
May encounter patients who are confused, agitated or abusive.
Must be available to travel locally, regionally, and nationally.
Office, clinical and hospital environment.
May include hours in the late afternoons, evenings, and/or weekends, depending on study assessments and participant scheduling requirements.
CITIZENSHIP AND CLEARANCE REQUIREMENTS:
Must be eligible to work in the US.
Must be able to pass a National Agency Check with Inquiries (NACI).
CICONIX, LLC is an Equal Opportunity Employer.
We E-Verify all employees.
Competitive market-based salary, commensurate with experience and education Comprehensive benefits available (Medical, Dental, PTO, 401k etc).
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Recommended Skills Analytical Assessments Basic Life Support Biology Clinical Research Clinical Research Coordination Estimated Salary: $20 to $28 per hour based on qualifications.
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