Clinical Research Project Manager

The Clinical Research Project Manager will be responsible for the overall coordination of project activities and perform a variety of research duties in support of the International Rare Brain Tumor Registry (IRBTR) program. Will manage assigned research projects and work collaboratively with the Brain Tumor Institute team and international partner sites and will report to the IRBTR Principal Investigator (PI). Will create, submit and maintain ongoing legal and regulatory documents for clinical trials, to include the preparation site agreements and IRB applications. Will work with the assigned partner sites to track subsite patient enrollments, manage transfer of patient data and materials, and ensure compliance with study protocol and the different grant funding agency and government clinical research policies. Will manage program budget, including executing orders and payments, creating spending projections, and periodic financial reporting. Will support the PI in ensuring that program activities align with funder/grant funding agency intent and policies and BTI clinical research priorities. Will monitor readiness of sites and their ongoing performance to enroll patients and submit data submission. Will support multiple projects and is expected to take initiative, be able to work independently and problem-solve.

Minimum Education
Bachelor's Degree BA/BS degree in science, technical, or health-related field with 3-5 year relevant experience or MS degree with 1-3 years relevant experience. .

Minimum Work Experience
1 year At least 1-4 years of multi-center clinical research experience. Or an equivalent combination of relevant education and/or experience. .

Required Licenses and Certifications
Desired Certification as a Clinical Research Professional (CCRP) or equivalent, or be in process of being certified. The current certifying bodies for clinical research professionals include Society of Clinical Research Associates (SoCRA) and the Association of Clinical Research Professionals (ACRP). .

Functional Accountabilities
Conduct of Research

• Consistently demonstrate adherence with the standards for the responsible conduct of research.

• Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator.

• Responsible for appropriate use of research funds and resources.

• Comply with all annual job-related training requirements.

Regulatory Documents and Project Development

• Maintain regulatory documents as per standard operating procedures as well as specific to the multi-center trial as set by the funding agencies and government regulations for the assigned projects (e.g. NIH, PCORI, FDA, etc.).

• Ensure regulatory integrity of protocols through preparation and submission of the protocol, consent forms, protocol amendments, and annual progress/continuing reviews to the IRB, and as appropriate, to the FDA, for approval.

• Assist and review other research sites with their ethics submissions.

• Assist in writing multicenter protocols and consent.

• Assist in the development of the assigned project manuals of operations.

Project Conduct

• Work with the assigned sites to prepare all study start-up activities and confirm assigned sites have the necessary approvals.

• Track data expectancy for the assigned sites.

• Perform remote and on-site reviews of study documents for assigned.

• Ensure all necessary data are gathered and recorded in the appropriate source documents, case report forms, and electronic data capture systems, review case report form entries for completeness, correctness and logical sense, during site monitoring visits.

Other Responsibilities

• Maintain regular communication with assigned study chair and sites.

• Collaborate with other departments (laboratory, research pharmacy, etc.), as necessary.

• Monitor expenditures for the assigned projects, work closely with the assigned financial personnel and data managers, who confirm data completion as part of approval of payments.

• Identify issues and challenges and work with the study's Coordinating Center Director to resolve any matters.

• Assist the PI of the multi-center study with the execution of the study investigator meetings; responsible for all logistics of the meeting

Professional Development

• Review journals, abstracts and scientific literature to keep abreast of new development and to obtain information relevant to clinical research programs.

• Attend and contribute to team meetings, including working to set and achieve project timelines and deliverables.

• Attend training or workshops of clinical research professionals as needed for growth.

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification

• Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

• Demonstrate collaborative and respectful behavior

• Partner with all team members to achieve goals

• Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance