Department/Unit:
Neurosurgery General
Work Shift:
Day (United States of America)
Research Coordinator - Neurosurgery
43 New Scotland Ave, Albany, NY
Coordinate research activities in the Department of Neurosurgery
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, faculty practice, pharmacy, radiology, laboratory medicine etc.)
Communicate and interact with NIH, 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, in-service education 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
Coordinate with AMC Faculty Practice registration staff to schedule follow-up study visits, treatments, testing and procedures appointments
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, recognizing the difference between the two, 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 and in compliance with IATA regulations
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
Qualifications:
Education
- Bachelor's Degree in a health related field required
Work Experience:
- 4-6 years of research or clinical experience required and 1-3 years as a research coordinator preferred
Knowledge, Skills and Abilities:
Successfully complete institutional credentialing as required
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
Salary Range: $45,308.00/annually - $72,492.00/annuall
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.
Albany Med is the centerpiece of medicine, research, and medical education in New York’s CapitalRegion and is the area's largest private employer with more than 10,000 employees.
Albany Med offers excellent career opportunities in a wide range of roles in both patient care andadministration. We value all our staff members and offer outstanding employee benefits including:
Excellent health care coverage (http://albanymedcareers.com/benefits/employee-health-%20benefits/) with lower copays at most Albany Med providers.
A wide array of services and programs to support emotional, physical, and mental wellbeing (http://albanymedcareers.com/benefits/employee-advantages/)
Anchored in the state’s historic capital city, Albany Med offers a full range outpatient and inpatient careand is home to the region’s largest hospital, only Level 1 trauma center, and only children’s hospital. Thedowntown campus also offers opportunities at Albany Medical College.
Albany Med partners with Columbia Memorial Health, Saratoga Hospital and Glens Falls Hospital to form the Albany Med Health System, serving more than three million people over 25 counties.