Under the general direction of the Principal Investigator and Research Nurse Manager, the Sr. Clinical Research Coordinator serves as a lead team member, subject matter expert and trial coordinator. Designs, implements, and coordinates both industry and physician sponsored research trials. This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the study protocols. Implements the research protocol through study closeout and ensures data validation, regulatory compliance, and quality control.

Facilitates physician initiated trials including protocol development, electronic data capture (EDC) implementation and management, information reporting, and ongoing monitoring of trials. Will ensure all project timelines are met.

• Serves as point person and lead for all assigned clinical trials including supporting other team members in study related activities. Utilizes advanced knowledge of clinical trials to serve as subject matter expert regarding protocols, regulatory compliance and sponsor relations.
• Collaborates with investigators and management to plan, implement, monitor, and coordinate clinical trials and study related activities
• Manages study data, ensuring proper collection methods, data quality, retention by team members.
• Conducts routine and advanced data analysis to identify trends, study direction and action items and for use in regulatory reporting and research publications by the principal investigator. Prepares reports for study sponsors and investigators to outline progress and support new opportunities in the trial or research. Prepares ad hoc reports to keep management abreast of the status of studies and operations.
• Participates in the development, implementation, and revision of study related processes, procedures, tools, and training as necessary to improve trial implementation. In conjunction with investigators and management prepares and monitors study budgets, tracks and reports expenses, submits expenses for payment in a timely manner, ensures expenses meet study targets and resolves variances.

Industry Sponsored Trials:

Coordinates assigned industry trials and ensures study goals are met. Day-to-day study responsibilities include:

* Reviews research subject medical records, abstracts data, completes the case report forms (CRFs), and records the information in the electronic data capture systems (EDC).

* Maintains meticulous records of all study patients and administers protocol specified questionnaires and assessments.

* Responds to queries and data entry in adherence to study-specific time-lines.

* Interacts with patients enrolled in the research protocols on a regular basis. This includes ensuring medication compliance in accordance with study/department protocols.

* Attends the study procedure in the OR and/or cath lab/Interventional radiology. This includes collecting study related data, as well as the delivery, tracking, and if needed return, of the investigational devices. Communicates and ensures compliance of the study protocol during the procedure.

* Performs activities to support the operational needs to clinical trials to include collecting and shipping of protocol-related lab samples and devices, ensuring investigational devices are ordered, received and securely tracked and ensuring protocol required imaging is done in accordance with protocol requirements and sent to the appropriate core labs in the specified format.

* Updates and obtains required approval from the MGH OR Products Committee regarding Vascular Surgery Research Devices and provides ongoing clinical trial documentation. Complies with the OR products committee requirements for product tracking.

* Supports administrative needs for each trial, including working with administrative staff to schedule patient protocol screening, study procedure, and follow-up appointments and confirming adequate research documentation is online in Epic. Follows hospital research billing processes and provides hospital billing department with appropriate information to ensure product reimbursement.

Physician Initiated Trials:

• Works with investigators to plan research data design, collection, analysis and reporting.

• Collaborates with study team to define and meet enrollment goals, study procedures and reporting expectations. Works with principal investigators to prepare study reports and papers for publication.

• Participates in the development and execution of non-industry supported study budgets focusing on the data collection, monitoring and analysis requirements.

• Obtains patient study data from medical records, physicians, on-site and off-site clinical information systems, etc.

• Conducts on-line and periodical literature searches.

• In collaboration with investigators and management, provides oversight during study visits and audits. This includes: arranging meetings, preparing associated materials, coordinating team debriefings, and lead follow- up related to action items.
  • Coordinates routine data monitoring visits/audits; including electronic medical record access, data entry and corrections, and query resolution. Coordinates and serves as a key resource during FDA audits.
• Serves as a liaison with various entities, including study sponsors, FDA, internal and Partners research resources and the hospital's Institutional Review Board (IRB). Cultivates and maintains effective working relationships to ensure open communication and partnerships that facilitate the division's growing clinical research program. Prepares documents and reports for the IRB including IDE Safety Letters, Protocol Amendments, Continuing Review Reports, Protocol Violations and Deviations, and Serious Adverse Event Reports as necessary
• Reports adverse events, serious adverse events, and unanticipated device adverse events in accordance with the protocol and the Partners Human Research Committee policies.
• Attends sponsor held coordinator meetings, making presentations regarding study status as needed.
• Attends sponsor and professional training; prepares and may present information gained at division staff meetings. Attends annual continuing education training related to clinical research and vascular surgery.
• Participates on or leads division or department committees regarding clinical research, process management and skills development.
• Serves as a lead member of the clinical trials staff, working with management to coordinate activities that support the team and its development.
  • Participates in applicant interviews and makes recommendations to management.
  • Coordinates and leads the onboarding of new clinical trial staff in collaboration with management. Participates in the creation and revision of the staff orientation program. Ensures orientation is complete and initial learning and competency attained. Provides feedback to management.
  • Develops and provides periodic training to research staff regarding research policies, practices, and regulations, including protocol implementation and compliance practices.
  • Provides functional oversight and guidance to and acts as a resource for other team members regarding questions, studies, regulations, etc.
  • Troubleshoots study process issues for self and team members, resolving complex concerns and collaborating with management and industry/study liaisons where necessary.
• May conduct staff meetings in the absence of management personnel.
• Participates in projects and other responsibilities as needed.

* Advanced understanding of clinical trial study design and protocols, data management and reporting

* Advanced working knowledge in Good Clinical Practice, FDA Code of Federal Regulations, and ICH guidelines

* Able to understand, interpret, communicate and train others on study protocols and data

* Ability to follow complex protocols, keep excellent written records and adhere to time-lines

* Understanding of clinical trials budget preparation and management

* Strong data management and analytical skills; some understanding or ability in statistical analysis helpful

* Obtains and maintains Partners Healthcare required GCP and CITI certifications

* Computer skills necessary (MS Word, Excel, Powerpoint and Outlook).

* Ability to effectively engage with and influence others; able to build working relationships; can work independently and as a team member, leading others when needed

* Strong written and verbal communication skills to support diverse constituents, including patients, physicians, sponsors, and staff from other departments throughout the hospital and affiliates

* Able to prepare materials for presentation and publication if needed

* Able to facilitate cooperation and teamwork both within the institution and with the corporate sponsor companies; effective skills in problem resolution

* Effective meeting management and presentation skills

* Adept at orienting and training new or temporary research staff

* Act as study resource for subject and family as well as colleagues

* Demonstrate respect and professionalism for subjects' rights, HIPAA guidelines, and individual needs of research subjects

* Is knowledgeable and compliant in all hospital, State and Federal regulatory requirements, including hospital policy and procedures (where applicable to the performance of the job), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA).

* Proficient with on-line medical literature database systems

* Ability to prepare and monitor research budgets

Education: BA/BS required in related field of study.

Experience: A minimum of 5 years of clinical research experience is required. Experience with multi-center study protocols required. Physician initiated (IDE or IND) trial experience preferred. Some direct experience working with the FDA on clinical trial audits is preferred.

• Normal office conditions. May be required to work in clinical conditions (including the operating room). May be exposed to minimal radiation.
• May be required to attend meetings outside of regularly scheduled hours and locations, including domestic travel
• On call schedule (dependent on enrolling trials) may be required.