Clinical Research Coordinator - Neurosurgery - #1408977

Department/Unit:

Neurosurgery General

Work Shift:

Day (United States of America)

Salary Range:

$51,755.37 - $77,633.06

The clinical research coordinator is responsible for the organization and management of multiple industry sponsored clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a research patient from initiation to completion of study. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening for eligibility, scheduling, and assessments, as well as data collection and study completion activities. The research coordinator serves as the liaison between PI and research site and the study sponsor and other vendors working on the trial.

Knowledge, Skills and Abilities:

• Self-disciplined with excellent organization and time management skills essential
• Must be reliable, flexible and possess excellent communication skills
• Establish a good working rapport with study patients, professional staff, department, institution, and sponsors, and be able to work as a team member
• Ability to work a flexible schedule to meet the needs of the research protocol visits
• Familiarity with office equipment (copiers, phones) and excellent personal computer skills including word processing, spreadsheet and database skills
• Ability to adapt to new computer platforms, including for uploading imaging
  
  

Essential Functions:

• Complete and submit protocol specific research site information, conflict of interest, financial disclosure and confidentiality forms as appropriate
• Maintain knowledge on each protocol’s specific inclusion and exclusion criteria, therapy, safety monitoring and data management requirements
• Communicate and interact with PI, research team, sponsor, IRB, Research Administration, and appropriate AMC departments (finance, pharmacy, radiology, laboratory medicine etc.)
• Communicate and interact with NIH, device or pharmaceutical companies, and clinical research organizations (CRO’s) as appropriate
• Prepare site for initiation of study by coordinating initiation and training site visits, and preparing documents, clinical units, administrative space and personnel for the study as appropriate
• Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials
• Complete mandated protocol training – electronic case report system, study specific equipment, and scales/scoring.
• Coordinate and conduct recruitment efforts and screening programs
• Conduct informed consent process; obtain consent and HIPAA authorization
• Enter study data for all enrolled patients into electronic data capture systems
• Create and maintain subject screening and enrollment logs, delegation of duty logs, adverse event logs
• Contact sponsor randomization system to randomize subject as appropriate
• Coordinate and conduct screening visits, develop study schedule, timelines, and deadlines with study patient, the PI and research team
• Administer/perform study scales and questionnaires
• Complete and maintain accurate source data documentation
• Communicate with subjects and families to monitor for adverse effects
• Ensure safety of subjects in the case of adverse and serious adverse events, documenting events, and reporting appropriately to sponsor and IRB
• Plan, prepare for and coordinate monitor site visits
• Obtain, process, store and ship clinical laboratory specimens per protocol, if applicable
• Extract information from source documents and electronic medical record system to complete electronic protocol case report forms
• Maintain records of study participation in subject's electronic medical record
• Review study data for completeness, accuracy and compliance with protocol requirements
• Coordinate secure maintenance and storage of all source and study documents, supplies and study equipment
• Coordinate study closure per protocol, IRB and regulatory agency guidelines, ensuring subject safety, preparing all necessary paperwork and summaries, returning unused supplies, and responding to any post study correspondence
• Collaborate with the PI for the protection of human subjects in all the above; follow FDA, OHRP and GCP regulations, ICH guidelines, and institutional policies and procedures
  
  

Thank you for your interest in Albany Medical Center!

Albany Medical is an equal opportunity employer.

This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that:

Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.