Senior clinical research coordinator job description

Job DescriptionDuties:
Job SummaryUnder general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists with protocol submissions, database enhancements, and budget preparation. Essential Duties and Responsibilities: 1. Analyzes highly complex data gathered on clinical research studies.2. Interprets complex clinical research data. Conducts clinical testing, develops protocols and assures all protocol procedures are approved.3. Prepares reports for presentation in conferences and seminars.4. Mentors, trains and reviews the work of less experienced clinical research staff.5. Develops work flow policies and procedures, prepares manuals and documents related to operations of the function.6. Oversees the clinical assessments of the study subjects including but not limited to screening, evaluation and testing of the subjects.7. Oversees data collection, processing, storage, inventory and quality control for clinical research studies.8. Assists in budget preparation and negotiation.9. May prepare and ensure grant applications, IRB / GCO documents are submitted.10. Coordinates protocols and human subject approvals between various sites.11. Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.12. Independently obtains informed consent for all types of clinical studies and educates participants regarding study requirements13. Performs other related duties.

Education:
Required: Bachelor's degree in sciences or related field.Prefered: Clinical Research Coordinator Certification granted by the Association of Clinical Research Professionals.

Languages:
English( Speak, Read, Write )

Skills:
Previous Experience3 years of clinical research experience Strong Knowledge of Industry sponsored clinical research Excellent written and oral communication skills Exceptional attention to detail and accuracy Ability to manage multiple tasks ; priorities Knowledge of variety of concepts, practices and procedures in directly related field Able to hit the ground running with limited training Equiptment: - Centrafuse

Minimum Degree Required: Bachelor's Degree

City: New York

Schedule:
Start Date: 11/07/2022
End Date: 02/04/2023
Schedule Notes: 9-5
Hours Per Week: 40.00
Hours Per Day: 8.00
Days Per Week: 5.00

• Requires Bachelor's degree (at minimum) in relevant life science discipline, RN (BSN) is preferred; certification as CCRC is a plus
• 3+ years previous experience working in a clinical setting; years clinical site/trials experience will determine position level
• Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
• Strong preference for experience with late phase and observational clinical research
• Managing necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc.
• Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects
• Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals and progress reports
• Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies
• Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats
• Clinical and laboratory skills, including the ability to perform phlebotomy and process samples is preferred
• Detail-oriented and meticulous in all aspects of work
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Superior organizational and time management skills
• Capable of working independently with minimal supervision and also as part of a team
• Ability to speak a second language based on site location and cultural competency are advantageous and preferred
• Understanding of medical terminology as well as standard clinical procedures and protocols

Company DescriptionBeacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.

Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.

Job DescriptionGENERAL SUMMARY/ OVERVIEW STATEMENT:

Working under the supervision of a Principal Investigator and following established policies and procedures, provides assistance on clinical research studies involving the identification of new ways to diagnose acute kidney injury in critically ill patients and those undergoing open heart surgery.

www.leaflab.org

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Provides assistance on clinical research studies per study guidelines and protocols.
• Creates and implements recruitment strategies for studies.
• Recruits, evaluates, and enrolls patients into clinical research studies.
• Obtains biological samples from patients in the hospital.
• Collecting data and maintaining patient information database for studies. Performs quality assurance checks for all clinical data.
• Work with Institutional Review Board to maintain protocol approval and current regulatory documentation.
• Assists study investigators with conferences and manuscript preparation, and any other data-related tasks.
• All other duties as assigned.
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  Qualifications
  QUALIFICATIONS:
  
  • BA / BS Degree
  • 3+ years of relevant experience
  SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
  
  • Ability to work independently.
  • Excellent interpersonal skills required for working with study participants.
  • Good oral and written communication skills.
  • Analytical skills and the ability to resolve technical or research problems and issues, and to interpret the acceptability of data results.
  • High degree of computer literacy.
  • Excellent organizational skills and ability to prioritize a variety of tasks.
  • Careful attention to detail.
  • Ability to demonstrate professionalism and respect for subjects rights and individual needs.
    
  
  
  EEO Statement
  BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Partner's Healthcare is acting as an Employment Agency in relation to this vacancy.