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Clinical Research Coord
2 months ago
Department/Unit:
Medicine - Community Endocrinology
Work Shift:
Day (United States of America)
The Clinical Research Coordinator is expected to provide organizational and management support for multiple clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies, from initiation to completion of study.
Job Description
+ Complete and submit protocol specific research site information, conflict of interest, financial disclosure and confidentiality forms as appropriate
+ Determine feasibility of study considering, appropriateness for patient population, maintenance of subject safety and confidentiality, fiscal soundness and logistical capabilities as appropriate
+ Knowledgeable on each protocols specific inclusion, exclusion, therapy, clinical monitoring oversight, laboratory evaluation, safety monitoring and data management requirements
+ Communicate and interact with PI, research team, sponsor, IRB, WIRB, Research Administration, appropriate AMC departments (compliance, finance, faculty practice, pharmacy, radiology, laboratory medicine etc.) as appropriate
+ Communicate and interact with NIH/NCI cooperative groups, pharmaceutical companies, clinical research organizations (CROs), and site research organizations(SROs) 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
+ Prepare and submit forms to establish research cost center - Departmental signature forms, Compliance checklist, Subject budget form, and Unrelated Income tax form Prepare AMCH and AMC Practice Research Patient Registration forms
+ Comply with all regulatory agency requirements and protocol guidelines in implementing clinical trials
+ Complete mandated protocol training electronic case report system, study specific equipment, study specific point of care testing, and scales/scoring.
+ Develop original source data documents Coordinate and conduct recruitment efforts, in-service education and screening programs Prepare and coordinate advertisement and media coverage efforts with appropriate AMC departments
+ Conduct informed consent process; obtain consent and HIPAA authorization Register patient as study subject with sponsor
+ Create and maintain subject screening and enrolment logs, delegation of duty logs, adverse event logs
+ Contact sponsor randomization system or request AMCH pharmacy to randomize subject as appropriate Coordinate and conduct screening visits, develop study schedule, timelines, and deadlines with study patient/family, the PI and research team.
+ Perform health assessment procedures as required by the protocol and as ordered by the PI (e.g. EKG, urinalysis, urine pregnancy testing, vital signs, obtain specimens etc.) Administer/perform study scales and questionnaires
+ Coordinate and work with AMCH and AMC Faculty Practice registration staff to schedule follow-up study visits, treatments, testing and procedures appointments
+ Coordinate dispensing of study therapy Ensure safety of study specific medical equipment used with research subjects, (e.g. EKG machine) via referral to Clinical Engineering; is prepared for emergencies, equipment failure, user errors and reports such events to management. Complete and maintain accurate source data documentation
+ Communicate on a continuous basis with subjects and families to monitor for adverse effects
+ Ensures 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, IRB and FDA.
+ Prepare and maintain accurate and complete source documentation and reports on unexpected and serious adverse study related event reports for submission to the sponsor/FDA and IRB, as required by the protocol and federal regulations
+ Protect subject confidentiality by assuring compliance with federal regulations and guidelines regarding confidentiality in storage, release of information and disposal of records.
+ Plan, prepare for and coordinate monitor site, pharmacy, audit and study termination visits Obtain, process, store and ship clinical laboratory specimens per protocol and in compliance with IATA regulations Extract information from source documents and complete paper-based and electronic protocol case report forms; maintain data integrity.
+ Review study data for completeness, accuracy and compliance with protocol requirements
+ Submit case report forms, subject logs, adverse event logs, query responses and protocol status reports to sponsors in compliance with the individual protocol design.
+ Prepare and submit Progress Reports, Annual Continuing Reviews, SUSAR reports, SAE reports, Unexpected Adverse Event reports to IRB of record Coordinate secure maintenance and storage of all source and study documents, supplies and study equipment.
+ Prepare invoices for sponsor payment per contract budget On a monthly basis, prepare requisitions for payment of AMCH/PBS and AMC Faculty Practice/MCPG research services
+ Coordinate study closure per protocol, IRB and regulatory agency guidelines, ensuring subject safety, preparing all necessary paperwork and summaries, returning unused supplies, complying with audits, and responding to any post study correspondence.
+ At all times throughout the study, collaborate with the PI for the protection of human subjects in all the above noted manner and always follow FDA, OHRP and GCP regulations and ICH guidelines and institutional policies and procedures. At all times throughout the study, coordinate the subjects health care in the interest of the patient first
Education: Bachelors or similar degree Minimum of 6 years of related research or clinical experience may be substituted
Experience and Skills:Previous experience in research, which can have been obtained during education Ability to multitask and exhibit an attention to detail.
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.
