Job Description

Function: this position facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies.

Principal Duties & Responsibilities:

• Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
• Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians
• Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections
• Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process
• Develops clinical study budgets based on proposed study protocols
• Coordinates approval of new study agreements and contracts
• Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits
• Completes case report forms. Extracts data from patient charts in a timely manner 
• Responds to data clarification requests in a timely manner
• May attend Investigator meetings requiring travel and report pertinent information back to research team members
• Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, RCA and sponsoring agency policies and procedures
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training
• Maintains subject screening logs and protocol deviation logs
• Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials
• Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors
• Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations
• Cooperates with Boston Foundation for Sight and sponsoring agency’s compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office
• Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for monthly
• Ensures that all materials for each clinical trial protocol are available for subject enrollment
• Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data
• Performs specimen processing and shipment of biological specimen duties
• Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required
• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, Boston Foundation for Sight, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures
• Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct 

Other Duties as Assigned:

The above information on this portion is designed to present the most essential duties and responsibilities necessary to achieve the positions end results. The occupant of this position is required to follow any other job-related instructions and perform any other duties as requested by Physician Director(s), Clinical Research Manager, and/or Practice Manager. It is the responsibility of each employee to assist other office staff when and where necessary. All employees have the responsibility of answering phones, maintaining files, filing, updating data, and receiving prescription refill orders, etc. Most importantly, it is each staff member’s responsibility to project and maintain a positive attitude toward all patients and fellow co- workers.  The duties listed may be changed or modified at any time.

Qualifications

• Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors
• Knowledge of medical terminology
• Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
• Familiarity with the Microsoft Office Suite
• Previous work with CRFs and EDC
• Excellent organizational skills to independently manage work flow
• Ability to prioritize quickly and appropriately
• Ability to multi-task
• Meticulous attention to detail

Education and Experience:

• B.S. preferred
• Two years in a clinical research setting, preferably working as a clinical research coordinator on Industry-Sponsored clinical trials.
• Psychiatry preferred