Study Start-up Project Coordinator I

St Luke's University Health Network Bethlehem, PA
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 assumes a critical role in the research process. The primary responsibility is for coordinating all study start-up activities and regulatory operations for Investigator-Initiated, Cooperative Group, and Industry trials. Ensure timely throughput time from initial sponsor contact, through protocol inception to study activation, serving as the primary liaison between the sponsor, PI, and study team, responsible for the timely completion of CDAs, Feasibility Questionnaires, pre-site visits, and site-initiation visits. Responsible for working closely with the Director of Clinical Trials and Research with budget and contract processes such as completion of Medicare Coverage Analyses (MCA) and review of protocol requirements for operation feasibility. Also responsible for ensuring that the regulatory documentation throughout the life of a trial meets FDA, study sponsor, and IRB requirements. Coordinate day-to-day regulatory workflow and serve as the regulatory liaison to the sponsors, contract research organizations (CROs), Investigators, IRB, and cooperative groups. Also responsible for the review, preparation, and submission of all clinical protocols to the IRB ensuring compliance with all local, state, ICH/GCP Guidelines, and Federal regulations. The Study Start-up Project Manager is responsible to obtain and ensure accurate maintenance of all regulatory documentation and tracking tools to ensure precise, audit-ready documents and timely submissions to all local and federal regulatory agencies.

JOB DUTIES AND RESPONSIBILITIES:

* Manage study start-up activities of clinical trials from initial sponsor contact, through protocol inception 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

* Ensure that all new potential clinical trials are moved through the study start-up process in a timely and efficient manner, including CDAs, questionnaires, feasibility review, MCA, budget and contract assistance, pre-site visits, site-initiation visits, etc., with the goal of activating trials in less than 90 days

* Develop and implement an internal feasibility review mechanism for all new potential clinical trials

* Oversee the regulatory workflow for 60+ clinical trials through the use of project management techniques and tools (e.g. spreadsheets, progress reports, priority setting of workloads, tracking logs, repositories, etc) from protocol inception until study closure

* Prepare regulatory documentation/submissions required for the opening of new studies, protocol amendments, informed consents, annual reviews to the IRB

* Establish and manage a Quality Assurance program to ensure that patient consent form is concordant with the current sponsor version, protocol and ICF version control is maintained, regulatory documents are quality checked before submission to the IRB and/or sponsor, and that all regulatory documentation is "audit ready" at all times.

* Demonstrates knowledge and practice of ICH/GP guidelines, HIPPA Regulations and Confidentiality Policy, and IRB policies elated to clinical research.

* Apply knowledge and skills to independently obtain and prepare new protocols and consents, annual review of protocols, amendments, IND Safety reports, and adverse event reports for IRB submission for all industry, Institutional, and cooperative group studies in an expeditious manner.

* Track IRB submissions, approvals and expiration dates for all protocols, including initial, annual and amendment submissions to ensure timely turnaround times.

* Collaborates with the Director and other clinical trials staff to develop procedures for management of all regulatory aspects of the clinical trials.

* Acquire the appropriate signatures for regulatory forms, and develop tracking tools for this process.

* Organize, prepare and maintain all essential regulatory documentation required by sponsor or CRO (1572s, Financial Disclosure Forms, Delegation Logs, CVs and Medical Licenses, deviation and exception memos, record of IRB certification and compliance, study and regulatory binders).

* Interface with representatives from sponsor, CRO, Cooperative Groups, IRB, staff, clinical trials staff, and investigators in the conduct of clinical trials to resolve any regulatory queries and/or issues. Collaborate with Director as appropriate to facilitate resolution of these issues.

* Is expected to work with minimal supervision to ensure operational efficiency.

* Submit data/records to cooperative groups/sponsors as appropriate (fax, Fed Ex, mail, etc.).

* Disseminates information to medical and nursing staff related to ongoing and upcoming clinical trials

* Participate in identifying department needs and supports department goals and objectives.

* Contribute to the growth of the Clinical Trials and Research Office.

PHYSICAL AND SENSORY REQUIREMENTS:

Requires sitting for up to seven hours per day, 3 hours at a time. Standing for up to 4 hour per day, 3 hours at a time. Requires occasional fingering, handling and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. Occasionally 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 required; will accept Associates degree or High School/GED degree with equivalent clinical research experience (5 years) with 1-2 years regulatory experience. Project Management experience preferred. Familiar with medical terminology.

TRAINING AND EXPERIENCE:

Required: Knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions. Experience in health-related field (2 years) required.

Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, 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.

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