Study Start Up Project Coordinator II
St.
Luke's is proud of the skills, experience and compassion of its employees.
The employees of St.
Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.
The Study Start-up Project Coordinator II is responsible for the coordination of all initial study start-up, regulatory, and activation activities for Industry, Cooperative Group, and Investigator-Initiated trials and ensures timely throughput time from initial Sponsor contact to study activation serving as the primary liaison between the Sponsor, JOB DUTIES AND
Responsibilities:
Manage study start-up activities of clinical trials from initial Sponsor contact to trial activation by maintaining a protocol development log and serving as the primary point of contact for investigators and Sponsors interested in opening a trial at SLUHN.
Manage the regulatory workflow for the clinical trial pipeline using project management techniques and tools (e.
g.
spreadsheets, progress reports, priority setting of workloads, tracking logs, repositories, etc.
) from protocol inception until study activation.
Ensure all new potential clinical trials are moved through the study start-up process in a timely and efficient manner, including CDAs, feasibility review and questionnaires, Billing Coverage Analysis (BCA), budget and contract, IRB approval, PSV, SIV, etc.
with the goal of activating trials in 75 days or less.
Develop and maintain real-time tracking of start-up activities and milestones with reportable metrics and identify and implement process improvements utilizing effective project management skills/tools.
Prepare for and Chair the department bi-weekly Oncology and Med-Surg Pipeline Meetings.
Facilitate internal study feasibility review for all new potential clinical trials with continuous evaluation for process improvement.
Prepare and track initial regulatory documentation, submissions and approvals required for the opening of new studies to ensure timely turnaround and escalate issues causing delays to department leadership during pipeline meetings.
Work closely with Sponsor to review and finalize study Informed Consent Form (ICF) that is compliant with all applicable regulations and guidelines as well as SLUHN IRB policies and procedures.
Prepare, obtain signatures, organize and maintain all essential regulatory documentation as required by Sponsor/CRO (1572s, Financial Disclosure Forms, Delegation of Authority Logs, Curriculum Vitaes and Medical Licenses, deviation and exception memos, record of IRB certification and compliance, study and regulatory binders) and develop tracking tools for this process to ensure completion.
Establish and manage a Quality Assurance (QA) program to ensure that patient ICF is concordant with the current Sponsor version, current protocol version and that ICF version control is maintained, that regulatory documents are quality checked before submission to the IRB and/or Sponsor, and that all start-up regulatory documentation is audit ready at all times.
Disseminate information to study medical, nursing, pharmacy, etc.
staff related to upcoming clinical trials as applicable.
Assist with scheduling and facilitating PSVs and SIVs.
Collaborate with department leadership to develop and/or improve standard operating procedures for management of all start-up and regulatory aspects of the clinical trials.
Interface with representatives from Sponsor, CRO, Cooperative Groups, IRB, staff, clinical trials staff, and investigators in the conduct of clinical trials to resolve any start-up and/or regulatory queries/issues.
Collaborate with leadership as appropriate to facilitate resolution of these issues.
PHYSICAL AND SENSORY REQUIREMENTS:
Requires sitting for up to seven hours per day, 5 hours at a time.
Standing for up to 4 hour per day, 3 hours at a time.
Requires frequent fingering, handling and twisting and turning.
Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds.
Frequently requires reaching above shoulder level.
Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
EDUCATION:
Bachelor's degree with 2-3 years of clinical research and direct regulatory experience required.
Master's degree with 1-2 years of clinical research and direct regulatory experience preferred; Clinical research certification (e.
g.
SoCRA, ACRP, etc.
) highly preferred.
Familiarity with medical terminology preferred.
TRAINING AND
Experience:
Required:
Knowledge of Microsoft Office Programs:
Word, Excel, Access, Outlook; Internet.
Demonstrates knowledge and practice of ICH/GCP guidelines, HIPAA Regulations and Confidentiality Policy, and IRB policies related to clinical research.
Please complete your application using your full legal name andcurrent home address.
Be sure toincludeemployment history forthe past seven (7) years, including your present employer.
Additionally, you areencouraged to upload a current resume, including all work history, education, and/or certifications andlicenses, if applicable.
It is highly recommended that you create a profile at the conclusion of submitting your first application.
Thank you for your interest in St.
Luke's!!St.
Luke's University Health Network is an Equal Opportunity Employer.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Luke's is proud of the skills, experience and compassion of its employees.
The employees of St.
Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.
The Study Start-up Project Coordinator II is responsible for the coordination of all initial study start-up, regulatory, and activation activities for Industry, Cooperative Group, and Investigator-Initiated trials and ensures timely throughput time from initial Sponsor contact to study activation serving as the primary liaison between the Sponsor, JOB DUTIES AND
Responsibilities:
Manage study start-up activities of clinical trials from initial Sponsor contact to trial activation by maintaining a protocol development log and serving as the primary point of contact for investigators and Sponsors interested in opening a trial at SLUHN.
Manage the regulatory workflow for the clinical trial pipeline using project management techniques and tools (e.
g.
spreadsheets, progress reports, priority setting of workloads, tracking logs, repositories, etc.
) from protocol inception until study activation.
Ensure all new potential clinical trials are moved through the study start-up process in a timely and efficient manner, including CDAs, feasibility review and questionnaires, Billing Coverage Analysis (BCA), budget and contract, IRB approval, PSV, SIV, etc.
with the goal of activating trials in 75 days or less.
Develop and maintain real-time tracking of start-up activities and milestones with reportable metrics and identify and implement process improvements utilizing effective project management skills/tools.
Prepare for and Chair the department bi-weekly Oncology and Med-Surg Pipeline Meetings.
Facilitate internal study feasibility review for all new potential clinical trials with continuous evaluation for process improvement.
Prepare and track initial regulatory documentation, submissions and approvals required for the opening of new studies to ensure timely turnaround and escalate issues causing delays to department leadership during pipeline meetings.
Work closely with Sponsor to review and finalize study Informed Consent Form (ICF) that is compliant with all applicable regulations and guidelines as well as SLUHN IRB policies and procedures.
Prepare, obtain signatures, organize and maintain all essential regulatory documentation as required by Sponsor/CRO (1572s, Financial Disclosure Forms, Delegation of Authority Logs, Curriculum Vitaes and Medical Licenses, deviation and exception memos, record of IRB certification and compliance, study and regulatory binders) and develop tracking tools for this process to ensure completion.
Establish and manage a Quality Assurance (QA) program to ensure that patient ICF is concordant with the current Sponsor version, current protocol version and that ICF version control is maintained, that regulatory documents are quality checked before submission to the IRB and/or Sponsor, and that all start-up regulatory documentation is audit ready at all times.
Disseminate information to study medical, nursing, pharmacy, etc.
staff related to upcoming clinical trials as applicable.
Assist with scheduling and facilitating PSVs and SIVs.
Collaborate with department leadership to develop and/or improve standard operating procedures for management of all start-up and regulatory aspects of the clinical trials.
Interface with representatives from Sponsor, CRO, Cooperative Groups, IRB, staff, clinical trials staff, and investigators in the conduct of clinical trials to resolve any start-up and/or regulatory queries/issues.
Collaborate with leadership as appropriate to facilitate resolution of these issues.
PHYSICAL AND SENSORY REQUIREMENTS:
Requires sitting for up to seven hours per day, 5 hours at a time.
Standing for up to 4 hour per day, 3 hours at a time.
Requires frequent fingering, handling and twisting and turning.
Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds.
Frequently requires reaching above shoulder level.
Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision.
EDUCATION:
Bachelor's degree with 2-3 years of clinical research and direct regulatory experience required.
Master's degree with 1-2 years of clinical research and direct regulatory experience preferred; Clinical research certification (e.
g.
SoCRA, ACRP, etc.
) highly preferred.
Familiarity with medical terminology preferred.
TRAINING AND
Experience:
Required:
Knowledge of Microsoft Office Programs:
Word, Excel, Access, Outlook; Internet.
Demonstrates knowledge and practice of ICH/GCP guidelines, HIPAA Regulations and Confidentiality Policy, and IRB policies related to clinical research.
Please complete your application using your full legal name andcurrent home address.
Be sure toincludeemployment history forthe past seven (7) years, including your present employer.
Additionally, you areencouraged to upload a current resume, including all work history, education, and/or certifications andlicenses, if applicable.
It is highly recommended that you create a profile at the conclusion of submitting your first application.
Thank you for your interest in St.
Luke's!!St.
Luke's University Health Network is an Equal Opportunity Employer.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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