Research Project Coordinator, Entry at Oregon Health & Science University in Portland, Oregon

Job Description:

Oregon Health & Science University

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.


Research Project Coordinator, Entry

US-OR-Portland

Job ID: 2024-32408
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Waterfront)

Overview

The Clinical Research Project Coordinator oversees and manages the day-to-day operations of clinical research activities for studies conducted at CEDAR. The Project Coordinator must understand how clinical and research operations work within the clinics/hospitals their team works in and the departments they collaborate with. They must have the ability to cover all roles that are part of the project and be the main point of contact for the study team members regarding operational aspects of clinical research, resolve issues and remove obstacles for study team members, assist in managing priorities, and identifies opportunities for process improvement. The Project Coordinator will also manage coverage issues related to sick calls and vacation time and may fill in to assist with responsibilities following a position vacancy. The Project Coordinator may mentor junior coordinators

In addition to leadership responsibilities, this individual maintains direct clinical research study management duties. Study management responsibilities include coordinating all aspects of a study as specifically outlined in the protocol and compliance with applicable regulations, including Good Clinical Practice. The candidate will work collaboratively with the investigator, study sponsors, clinical trials team, and other OHSU departments in the execution and management of subject research activities. The candidate will maintain accurate, complete, and timely records on research subjects that may include the preparation of source documentation and clinical research data/case report forms. The candidate can represent the investigator during monitor visits and on-site audits conducted by the sponsor or sponsor representative. The candidate may assist the Regulatory coordinator(s) with the IRB submission, to include preparation of consent forms and other documents required for IRB review.

Key Responsibilities:

• Study Lead Responsibilities
  • Act as a resource for study coordination team members
  • Act as a go between with the trial manager to synthesize the state and needs of the team
  • Meet with team members on a regular basis to monitor and assess workload, establish study priorities, and help escalate identified issues to the manager as needed
  • Facilitate and actively participate in new personnel training in collaboration with the Clinical Trials Manager and other staff members
  • Identify need for retraining of personnel as issues are identified and ptovide training on study procedures
  • Participate in clinical trials plan and act as lead on projects.
  • Keeps Clinical Trials Manager appraised of overall project performance (i.e., staffing or resource needs, completion dates, changes/delays in scheduling, etc.) and study portfolio management
  • Identify study process improvement opportunities, assess needs, implement solutions and evaluate effectiveness, in collaboration with Clinical Research Manager
  • Develop study transition plans for on-boarding new staff or off-boarding of staff leaving their positions, in collaboration with the Clinical Trials Manager
  • Provide general input and recommendations on personnel performance, workload, and team resource needs (i.e., supplies, OHSU system access requests, equipment, etc) to Clinical Trials Manager
  • Assist Clinical Trials Manager in screening and interviewing potential applicants for vacant study team positions.
  • Lead study team meetings
  • Advise the Clinical Trials Manager on strategic planning and study portfolio planning
  • Learn and maintain working knowledge of oncology diseases relevant to the clinical trials.
  • Perform data review on studies to verify that key data has been captured in source. Work with study team members to report any non-compliance to study investigator, sponsor, IRB, and departmental staff.
  • Prepare any necessary materials for required internal and external (sponsor, FDA) regulatory and quality control audits and sponsor monitoring visits.
  • Track and report adverse events and serious adverse events for studies to study investigator, sponsor, and IRB and ensure maintenance of adverse event documentation.
  • Oversee clinic operations including space allocations, staffing, and check-off on staff training
• Study Operations:
  • Support day-to-day operations related to study clinical research activities through problem-solving of systemic issues and escalates to Clinical Trials Manager, as appropriate
  • Provide clinical research management coverage for study staff and vacant positions, as needed. This includes, but is not limited to, facilitating coverage for staff that is out of the office for planned time off, securing coverage for sick calls, serving as backup coverage when there are gaps, and escalating coverage gaps to the Clinical Trials Manager.
  • Assists Clinical Trials Manager with study finance activities, including but may not be limited to, review of clinical research billing grids, review of study budgets, invoicing and billing reconciliation
  • Work with Regulatory coordinator(s) and Clinical Trials Manager to activate new trials. This may include conducting study feasibility, hosting site visits, and identifying potential trials for study portfolio.

  • Resolve queries, discrepancies, and inconsistencies found in study data

• Clinical Research Responsibilities:
  • Keep Principal Investigator up to date on key study information
  • Assure appropriate conduct of protocol according to applicable regulations
  • Enroll patients in clinical trials
  • Obtain Informed Consent
  • Explain trial logistics
  • Review medical records for eligibility criteria
  • Schedule study required assessments
  • Process of human specimens for research
  • Obtain vital sign measurements for study patients
  • Document interactions with study subjects and vital signs as appropriate
  • Documentation: Complete case report forms/data entry
  • Create study calendars and research subject charts
  • Review medical record and abstract relevant data

Responsibilities

Education & experience:

• Bachelor's in relevant field AND 1 year of relevant experience OR
• Equivalent combination of training and experience
• 1 year of prior experience in Clinical Research Management (with Bachelors), or equivalent combination of training and experience
• Experience working within a team and managing deadlines

Knowledge, skills, and abilities:

• Ability to prioritize multiple tasks at one time
• Must have excellent communication, analytical, and organizational skills, both written and verbal.
• Ability to work independently and as part of a team while collaboratively resolving problems.
• Must be proficient with computers running Windows and PC applications, g., MS Excel, Oracle, Access, Word, and PowerPoint).
• Must have demonstrated excellent customer service skills both on the phone and in person.
• Must possess energy and drive to coordinate multiple projects simultaneously.
• Ability to use tact and diplomacy to maintain effective working relationships
• Keen attention to detail
• Strong troubleshooting skills

Qualifications

Education & experience:

• Experience working in an academic office environment.
• Experience with clinical trial recruitment and regulatory submissions
• Experience with outreach events

Knowledge, skills, and abilities:

• Familiarity with medical terminology.
• High level of organization, attention to detail, troubleshooting, and prioritizing skills is preferred.
• Prior experience supervising direct reports OR mentoring junior staff

PI255601274

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