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Clinical Research Coordinator

TekWissen LLC

New York, NY

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JOB DETAILS
SALARY
$45–$47
SKILLS
Analysis Skills, Auditing, Biology, Cancer, Case Report Form (CRF), Cell Biology, Certified Clinical Research Coordinator (CCRC), Clinical Information, Clinical Information Systems, Clinical Laboratory, Clinical Research, Clinical Study Publications, Clinical Trial Management, Communication Skills, Computer Skills, Computer Software, Customer/Client Research, Data Analysis, Data Collection, Data Entry, Data Formats, Data Quality, Database Administration, Diversity, Documentation, Electronic Medical Records, Funding, Graphics Software, HIPAA (Health Insurance Portability and Accountability Act), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Immunology, Internet Search, Laboratory Testing, Maintain Compliance, Medical Office, Medical Records, Medical Research, Medical Terminology, Organizational Skills, Patient Registration, Publications, Quality Assurance, Regulations, Regulatory Compliance, Reporting Skills, Research Administration, Research Protocols, Risk Management, Spreadsheets, Statistics, Surgical Procedures, Translational Research, Trend Analysis, Word Processing, Workforce Management, Writing Skills
LOCATION
New York, NY
POSTED
2 days ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a world-leading cancer treatment and research institution based in Manhattan, New York. Founded in 1884, Our client is now a premier National Cancer Institute designated comprehensive cancer center. Its integrated care model bridges personalized patient treatment with innovative translational research in cancer biology, immunology, cell biology, and more. The institution remains committed to "ending cancer for life" through top-tier clinical care, ambitious research programming, and ongoing clinical trials.

Job Title: Clinical Research Coordinator
Location: New York, NY 10021
Duration: 12+ Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
  • As an integral member of the Clients 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 Client.
  • Ensures data quality and integrity during each phase of data collection and for each protocol assigned.
Data Collection/Data Entry: Utilizes appropriate methodologies to collect human subject information for a research project, database, and/or protocol.
Performance Expectations:
  • Performs abstraction of data from source records in patient/human subject records (e.g., electronic medical record, laboratory or diagnostic test results, surgical/radiation treatments delivered); abstraction of data from publications, or data collection from outside physicians' offices.
  • If applicable, completes necessary data collection requirements for interdepartment research projects, databases, and/or protocols.
  • Redacts source documentation as needed to ensure compliance with the Health Information Portability and Accountability Act (HIPAA) and other regulations.
  • Uses research databases (e.g., sponsor electronic Case Report Forms, Medidata, RedCAP and Clinical Trials Management System (CTMS)) etc. efficiently to complete assigned tasks.
  • Enters data into the relevant data collection systems as per established protocol or project timelines.
  • Ensures data are accurate and complete.
  • Recommends changes/additions to established data fields, if needed.
  • Performs queries in databases to identify missing data variables.
  • Utilizes the Clinical Trial Management System (CTMS) with accuracy and timeliness registering patients and tracking visits.
  • Stays up-to-date with system changes that affect job responsibilities.
  • Attends required Clinical Research Administration (CRA) training, protocol training classes and systems training (e.g. CTMS Training).
  • Attends departmental research meetings or service trainings, as needed.
  • May recruit, consent, interview and collect relevant data from human subjects enrolled to non-therapeutic, minimal risk studies for selected departments at the discretion of the Manager.
Data Reporting:
  • Generates reports to all necessary parties on the progress of the research project, database, or protocol.
  • Facilitates and acts as primary liaison for monitoring visits and audits conducted by outside sponsors or internal CR QA.
Performance Expectations:
  • Generates reports for Principal investigator, sponsoring agency, Institutional Review Board, DSM Committees, manager etc., as needed.
  • Compiles data and assists in consolidating/analyzing data for presentation.
  • Performs and/or responds to queries and/or assist with statistical analyses, as needed.
  • Provides real-time updates on data entry status to study team and supervisor.
  • Communicates to the manager or study team when there are any issues or questions regarding missing or incomplete participant data and identifies trends or gaps in source data availability or accuracy.
  • Meets regularly with the manager or study team members to review study data progress.
  • Reviews monitoring queries and enters appropriate data in the CRF.
  • For complex queries, partners with clinical team (CTN, physician) to obtain responses to questions and then enters data in the database.
Quality Assurance:
  • Participates in activities to ensure accurate and complete data and regulatory compliance.
Required Skills & Experience:
  • Client will allow any amount of experience. If there is none, this should be escalated.
  • Medical/Research Experience required with HS diploma/GED.
  • Beginner written communication skills including composing written correspondence and presenting information in a clear and concise manner.
  • Beginner analytical skills including the ability to abstract information from clinical documents and enter data into the appropriate database.
  • Ability to enter data accurately.
  • 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.
  • Computer Skills: The ability to use a computer and software such as database management, spreadsheet, word processing and graphics applications.
Preferred Skills & Experience:
  • Two-four (2-4) years of experience preferred.
  • Medical/Research Experience preferred with Bachelor's degree.
  • A strong familiarity with Internet searching.
  • Medical terminology and an interest in science.
  • Medical/Research Experience.
Required Education: HS Diploma/GED.
Preferred Education: Bachelor's Degree.

Preferred Certifications : Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP).
TekWissen Group is an equal opportunity employer supporting workforce diversity

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/

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