Clinical Trial Protocol Project Manager

The Hope Foundation

SWOG Cancer Research Network Operations Office

Position: Protocol Project Manager

Job Type: Full-Time (1.0 FTE), Exempt

Location: San Antonio, TX

Compensation Package: Competitive salary, Paid Vacation and Sick Leave, Health, Dental and Vision Benefits, Short-Term Disability Insurance, Life Insurance, 403b package with Employer Match.

Description:

Coordinates all aspects of SWOG scientific studies (protocols) from initial concept to study completion and termination for selected Disease Committees and Discipline Committees. Independently sets goals for and follows up with representative to the project team to ensure that timelines are maintained.

Accountability:

The Protocol Project Manager reports to the Clinical Trials Program Manager.

About The Hope Foundation:

The Hope Foundation is a nonprofit public charity, created with the mission of supporting the research and education programs conducted by SWOG in efforts to eradicate adult cancers. The Foundation has awarded over $20million to SWOG programs and projects, contributing to Fellowships, Continuing Education for Physicians, Nurses and CRAs, and supplemented clinical trials funded through the National Cancer Institute. For more information, please visit our websites: http://www.thehopefoundation.org or http://www.swog.org.

Responsibilities:

· Management of the protocol developmental process and related correspondence for assigned Committees. Includes mailings to Committee membership (e.g., protocol review), dissemination of protocol critiques to appropriate Group members, and monitoring of each step of protocol development for each assigned study to assure timely activation and patient accession. Responsible for submitting Letter of Intent or Concept Sheet, protocol documents, Funding Memorandum, and any additional study materials requiring pre-approval to National Cancer Institute (NCI) and Central Institutional Review Board (CIRB) for approval.

· Composition of protocol document. Includes editing, development of protocol draft to final document per SWOG protocol guidelines, proofing of typed protocol documents, and verification of the incorporation of standard information. Responsible for assuring that input/comments are obtained from appropriate disciplines/modalities of the Group and included into the final protocol draft. Responsible for modification of the protocol based upon NCI/CTEP/DCP/CIRB review.

· Maintenance of active protocols within assigned Committees. Includes the development of amendments, revisions, closure notices (temporary or permanent) and re-activation notices as directed by the Disease Committee Chair, Study Chair, NCI and/or Statistics and Data Management Center. Also includes responsibility for submission, tracking and modification of protocol changes based on NCI/CTEP/DCP and Central IRB review. Create content for and updates the Group web site and database as necessary.

· Liaison between the National Cancer Institute, Central IRB, Executive Officer, Disease Committee Chair, Statistics and Data Management Center, Discipline Chair(s) and Study Chairs for proposed and active protocols. This would include relating comments/changes from one Chair/representative to remaining participants to assure timely finalization of protocol, and updating the status of study to Group members on a continuing basis.

· Attend semi-annual SWOG meetings and provide updates on study status at appropriate Committee meetings as necessary.

· Participate on projects as directed by the Group Chair, Director of Operations and Protocols, and Clinical Trial Project Managers.

· As deemed necessary, meetings, conference calls or other responsibilities may be required outside of normal working hours

Requirements:

The preferred educational background for the Protocol Project Manager is a Bachelor of Science undergraduate degree or higher (Bachelor of Arts acceptable with significant science coursework as shown on transcript). Other experience: three to five years’ experience in the medical research field requiring the exercise of initiative and the ability to complete tasks with a minimal amount of supervision; significant composition, editing and computer skills (word processing, data entry) required. Prior experience with Microsoft Office (Word, Outlook, Excel, PowerPoint, and Office 365) is preferred. At least one year experience as a Protocol Coordinator I is preferred. Excellent spelling and medical terminology skills are essential. This position requires flexibility, creative problem solving and organizational skills as well as competence in typing 45 wpm and drafting correspondence.

Job Type: Full-time

Pay: $59,000.00 - $63,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in San Antonio, TX 78229

Salary : $59,000 - $63,000