TI Sr Clinical Research Associate

The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug infusion and gene therapies for treating patients with cardiac diseases including hypertrophic cardiomyopathy amyloidosis and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions.

The position is on point for all regulatory work organizing and leading monitoring visits with sponsors preparation and of activities needed during an FDA audit and working with leadership on projects relating to study startup. They also serve as a mentor to junior research staff in the group is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group as well as developing standardized workflows and SOPs for the program. Lastly this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development.

The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification reporting of and followup of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.

The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following:

IRB Protocol Management and Development

• In collaboration leadership and based on sponsor protocol develop and submit new IRB protocols for review.
• Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated
• Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date including updated staffing information accurate term dates and that amendments and continuing reviews are submitted timely when adjustments are needed.
• Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes and address regulatory gaps with IRB protocols.

Study Documentation

• Monitor and ensure documentation storage meets FDA institutional and sponsor guidelines.
• Oversight and maintenance of all regulatory binders for each study
• Ensure proper filing of all study correspondence between study team and sponsor for audit purposes
• Ensure proper filing of all correspondence between IRB and study team for audit purposes
• Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes
• Ensure centralized documentation of all monitor visit reports. This includes site selection site initiation monitoring visits and closeout reports

Audit Support/Preparation

• Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed.
• In collaboration with leadership identify at risk trials and perform an indepth internal review.
• Provide standardized reporting of all relevant findings including possible action items and areas for retraining or process changes.
• Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership.

Monitoring Visits

• Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit
• Meet and provide any needed information or data to the monitor during the visit
• Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps.
• Ensure all documentation postvisit is entered into EPIC and EDC
• Responsible for direct sponsor correspondence regarding patient safety responding to queries reporting adverse events conduction of visits etc.

• Masters Degree in relevant field AND 3 years of clinical research coordination experience OR Bachelors Degree in relevant field AND 5 years of clinical research Coordination experience
• Strong interpersonal communication skills and excellent attention to detail
• Critical thinking skills to anticipate and address potential problems

• Very Strong understanding of Research Regulations and best practices

• Strong knowledge of FDA regulations and audit preparation practices
• Strong data abstraction and project management skills
• Ability to prioritize multiple tasks at one time
• Strong teaching skills with the ability to mentor junior staff
• Must have excellent communication analytical and organizational skills: both written and verbal.
• Ability to work independently and as part of a team while being collaborative in resolving problems.
• Must be proficient with computers running Windows and PC applications e.g. MS Excel Oracle Access Word and PowerPoint).
• Must have demonstrated excellent customer service skills both on the phone and in person.
• Demonstrated ability to work with a variety of diverse individuals and personalities.
• Must possess energy and drive to coordinate multiple projects simultaneously.

• Ability to use tact and diplomacy to maintain effective working relationships

• Masters degree
• 5 years of experience in coordinating clinical trials
• Experience in coordinating trials in cardiovascular medicine
• Experience managing regulatory activities for clinical trials
• Previous experience at the Research Associate or Senior Coordinator level
• Prior experience leading clinical research teams and mentoring junior staff

Location: Marquam Hill & South Waterfront Campus

Schedule: Monday Friday 6am 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As salaried employee senior coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another.

Must be able to travel to all KCVI worksite locations including potentially using the tram numerous times each day. Will work with human biological samples including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves masks etc. as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires succesful completion of BLS certification.

Due to the increased focused writing and focused attention on creation of sensitive study startup regulatory materials this position is permitted to work remotely 1 day per week to complete this portion of the role.

The other aspects of this role are patient facing onsite role. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times this severely restricting the ability to conduct work remotely.