- Responsible for overall on-site monitoring activities of assigned clinical sites.
- Observe participant clinic visits and provide feedback to study coordinators on adherence to trial protocol and operations manual, as appropriate.
- Perform Informed Consent Form (ICF) reconciliation to ensure all trial subjects have fully completed and signed the correct version of the form. Collect and submit other regulatory documents as necessary.
- Effectively perform protocol and other on-site study training to investigator and site study staff.
- Perform drug and/or device accountability.
- Review ISF and resolve noted deficiencies in a timely manner.
- Identify and resolve site level Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with Clinical Trial Protocol Coordinators.
- Perform Trial Master File maintenance.
- Co-monitor as needed or facilitate co-monitoring visits from the trial sponsor or TIMI.
- Attend and participate in investigator and coordinator meetings as requested.
- Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.).
- Available to support site staff for studies not currently involved in performing on-site monitoring
- Ability to audit monitor performance for studies not currently performing on-site monitoring, as requested.
- Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations related to Field Monitoring.
- Maintains department service standards as outlined in the BWH Code of Conduct.
- Performs other duties as required.
- Ability to accept a responsibility for decision-making as it relates to the conduct of field monitoring for large domestic and international clinical trials.
- Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities.
- Outstanding interpersonal and leadership skills to effectively interact with Sr. Management, Principal Investigators, Trial Staff, and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international).
- Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds, and to function effectively as a member of a research team.
- Outstanding organizational abilities to formulate and complete rigorous timetables.
- Ability to travel nationally on short notice
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Clinical Research Monitor BWH Timi Study Group - Boston, United States - Partners Healthcare System
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Field Clinical Research Associate (Field Monitor) is primarily responsible to ensure the assigned site study staff conduct the study in compliance with the currently approved protocol/amendment(s) and trial operations manual.
The position will perform on-site visits, such as Qualification, Site Initiation, Interim Monitoring and Study Close-out Visits, in accordance with the Monitoring Plan.
Field Monitor will comply with TIMI's Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH)/Good Clinical Practices (GCPs), and applicable regulatory requirements.
Responsibilities may also include observation of participant visits, performing source document verification, query resolution, triaging site issues, conducting staff training and collaborating with in-house Clinical Trial Protocol Coordinators, to ensure regulatory documents and the Investigator Site Files (ISFs) are complete and current.
May also serve as a mentor and coach to junior staff.PRINCIPAL DUTIES AND RESPONSIBILITIES:
Includes but is not limited to:
a.
Independently conduct all types of monitor visits, onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote visits as needed, in accordance with the Monitoring Plan.
b.Perform source document verification/review in accordance with the Monitoring Plan
c.
Schedule and conduct visits in accordance with the Monitoring Plan
d.
Complete monitoring visit reports and enter them into an electronic database, confirmation letters, and follow up letters on time, in accordance with Monitoring Plan and/or TIMI SOPs and Guidelines.
Minimum of 5 years in clinical trial related experience for large, multi-center national and/or international clinical trials or 3 years of TIMI specific experience.
Certified Clinical Research Professional (CCRP) or equivalent and/or Certified Clinical Research Associate (CCRA) preferred.
Experience with cardiovascular studies and medical terminology preferred.
Knowledgeable of Electronic Data Capture Systems (e.g InForm, eCOS, IWRS) preferred.
Working knowledge of HIPAA
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
WORKING CONDITIONS:
May be expected to conduct 8-10 field visits per month, although percent of travel is dependent on study specific need.
FISCAL RESPONSIBILITIES:
Will be required to complete expense reports in accordance with TIMI Study Group expense guidelines.
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