Please see job description in full details below – Organization seeking to hire Veterans – Ideally for E-4 to E-6 ranking. If interested please submit resume for consideration to: firstname.lastname@example.org
Job Title: Research Study Assistant I
Dept. Name: Various
Reports To: Manager, Clinical Research / Coordinator, Clinical Research /Etc.
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, performs data collection, data entry and data analysis for research projects, databases, and research protocols within. Ensures data quality and integrity during each phase of data collection and for each protocol assigned.
DUTIES AND RESPONSIBILITIES:
1. Responsibility Title: DATA COLLECTION
Responsibility Detail: Utilizes appropriate methodologies to collect human subject information for a research project, database, and/or protocol.
Performs abstraction of data from source records in human subject charts (e.g., laboratory or diagnostic test results, surgical /radiation treatments delivered, adverse drug reactions, Health information System (HIS), etc.); abstraction of data from publications, or data collection from outside physicians’ offices.
Uses research databases (e.g. CRDB, Access, Excel, Case Report Forms) efficiently to complete assigned tasks. As needed, attends training classes for understanding of program (e.g. CRDB Training).
According to protocol guidelines, recruits and interviews human subjects for research studies, when requested. Collects and records all research data and ensures completeness of information.
Enters data into the relevant data collection form (e.g., CRDB, various PC-based systems, Case Report Forms) as per established protocol or project timelines. Assists with and/or designs tools (e.g. human subject calendars, schedules, tracking logs) to ensure data collection is performed within established timeframes, or as directed by supervisor. Recommends changes/additions to established data fields.
If applicable, completes necessary data collection requirements for inter-department research projects, databases, and/or protocols.
Attends departmental research meetings or service trainings, as needed.
Percent of time: 25%
2. Responsibility Title: DATA REPORTING
Responsibility Detail: Generates reports to all necessary parties on the progress of the research project, database, or protocol.
Generates reports (e.g. DSMC reports, Toxicities reports, minimal data set reports) for Principal investigator, sponsoring agency, Institutional Review Board, etc., as needed. With assistance from supervisor, ensures that Serious Adverse Events (SAEs) are completed, and reported to the SAE Office in the Office of Clinical Research, and sponsor if necessary, as soon as possible, per institutional and protocol requirements.
Compiles data and assists in consolidating/ analyzing data for presentation. Performs and/or responds to queries and/or assist with statistically analyses, as needed.
Updates supervisor with important research study information daily or as appropriate. This includes, study progress updates, any new toxicities or Serious Adverse Events (SAEs), outside communications received by sponsors or cooperative groups, any problems with human subject registration or informed consent process, and requests from investigators or research staff.
Communicates to the Principal Investigator (PI), when there are any issues or questions regarding participant eligibility, protocol timelines, etc. Meets regularly with the PI to review study progress.
Coordinates with OMS and/or research team to create protocol specific Research Non Billable order sets, as needed.
Percent of time: 25%
3. Responsibility Title: QUALITY ASSURANCE
Responsibility Detail: Participates in activities to ensure accurate and complete data and regulatory compliance.
Performs self-audits to ensure protocol compliance.
Reviews data collected for typographical errors and consistency with source documentation.
Ensures data compiled is clear, the calculations are accurate and the data meets all necessary data collection requirements. Ensures all source documentation that supports data collected is available for review.
Works closely with Research Manger and/or Principal Investigator in the preparation of Data and Safety Monitoring reports (e.g., TRRC, DSMC, DSMB), as needed.
Notifies supervisor and/or PI of protocol violations, deviations, etc., and ensures timely reporting to the IRB/PB.
Ensures Corrective Action Plans are distributed and implemented, with guidance from supervisor.
Prepares for internal and external audits or monitoring visits of a protocol (e.g. pre-visit chart review, ensures regulatory binder is complete) and may independently represent the study upon site visits by such groups as external industry representatives and internal monitors.
Attends training programs, modules, workshops, seminars, disease-specific meetings, and meetings with Principal Investigator, when directed by supervisor, to keep up-to-date on project objectives and new policies for conducting human subject’s research.
Participates in and promotes the prevention, detection and resolution of instances of noncompliance with departmental and institutional billing policies and procedures.
Percent of time: 20%
4. Responsibility Title: REGULATORY COMPLIANCE
Responsibility Detail: Ensures that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures that research protocols are approved by the Institutional Review Board and followed as written.
Completes all required certifications per institutional requirements (e.g., Human Subjects Protection, HIPAA)
Collaborates with the research team to ensure that human subjects are treated in accordance with all mandated Human Subjects Protection regulations and policies.
Ensures research projects, databases, and/or protocols follow Human Subject Protection Federal Regulations and institutional policies for conducting clinical research and/or collecting data into databases.
Accesses, uses and discloses protected health information per institutional, state and federal requirements.
For protocols, registers all consented human subjects within 48 hours of date of consent, and according to institutional policies.
For protocols, ensures that the consent/research authorization documents are signed and dated correctly and scanned into the relevant e-medical record weekly. Maintains, as per department/service policy, non-patient consent files for our human subjects.
Maintains and updates protocol regulatory binder(s) as necessary, per institutional policy.
Ensures standard steps regarding human subject registration, protocol specific tests, and required documentation are consistently followed both within and participating institutions, if applicable.
For non-CRDB databases, ensures registration in the Database and Reagent Registry. Follows all applicable departmental and institutional policies and procedures related to billing including documenting RNBs as appropriate.
When directed to handle, package or ship Dangerous Goods, applies institutional, state and federal policies, and applicable trade union requirements. Dangerous Goods include biological specimens (including but not limited to tissue specimens, blood, and sputum), dry ice, and chemicals. Meets time intervals for shipments as dictated in the protocol.
Percent of time: 20%
Responsibility Title: ADMINISTRATIVE AND CLINIC SUPPORT
Responsibility Detail: Provides clerical support, as needed for research projects, databases or protocols; provides research support in clinic.
Follows up with human subjects via correspondence/telephone. Confirms identity of all human subjects before engaging in conversation or giving information according to established institutional policies and procedures.
Coordinates human subject’s protocol schedules with other areas/departments considering human subject’s complete day/procedures.
Provides clerical support, as needed, (eg photocopying, delivering, filing, typing) including but not limited to, protocol development, amendments, questionnaires, Investigational New Drug (IND) applications, abstracts, poster and oral presentations, and requesting/mailing pathology slides or radiology films.
Schedules conferences for investigators, as needed.
Performs journal/internet searches, as needed.
Performs blood spinning and transferring of blood products, specimens and/or slides, as specified in the research protocol, and as requested by supervisor.
Prepares Dangerous Goods for shipment, as needed.
Percent of time: 10%
Military – E-4 to E-6
Type of Experience: Research or other relevant experience (analysis, financial, etc.)
Preferred Education (optional): A Bachelors degree is preferred.
SPECIAL SKILLS AND ABILITIES:
(Required specialized skills and abilities.)
Medical terminology and an interest in science are helpful. This position may require the incumbent to complete tasks of standard to moderate difficulty under limited supervision and/or to assist more senior research staff in working on more difficult assignments.
Communication Skills: The ability to compose written correspondence and to present information in a clear and concise manner.
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff, patients and human subjects at MSKCC as well as appropriate external contacts.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet deadlines.
Administrative Skills: The ability to organize and maintain all research information for assigned project and to ensure adherence to established policies and procedures within and from external regulatory/sponsoring agencies.
Computer Skills: The ability to use a computer and software such as database management, spreadsheet, word processing and graphics applications. A strong familiarity with Internet searching is preferred
|1. Does this job directly supervise other positions: No|
(Types and frequency of physical effort, e.g. lifting, visual concentration)
Frequent visual concentration in the abstraction, input, and retrieval of data. Frequent movement throughout the hospital’s main campus and other Manhattan office sites, and visits to ambulatory sites as needed (e.g., network sites, community based facilities) in order to collect information regarding the human subject visit.
(Summarize, include disagreeable conditions or potential hazards)
Normal hazards which are involved with a hospital environment and exposure to patients.
Works 9:00am – 5:00pm or 3:00pm – 11:00pm, as scheduled.