Clinical Project Coordinator Job 2024 Full Time

The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.

PHI was distinguished as one of the top 50 “Best Non-Profit Organizations to Work For” by the Non-Profit Times in a national search.

Position Summary

The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The COG unites more than 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Our goal is to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

The Clinical Project Coordinator will be responsible for coordinating COG projects that involve outside collaborators within the pharmaceutical industry. The Project Coordinator will ensure COG maintains its contractual commitments, obtain any materials from the sponsor that are relevant to study conduct and assist with the financial management of industry trials.

This is a regular full-time remote position.

Full salary range for this position: $62,968 to $90,167 per year. The typical hiring range for this position is from $62,968 (minimum) to $76,568 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Essential Duties & Responsibilities

• Coordinate meetings and teleconferences for Industry Sponsored Trials.
• Manage the distribution of Work Order Reports, Study Progress Reports, Study Summary Reports, Sunshine Reports to industry partners per the timelines outlined within the contract and track the distribution of the materials.
• Circulate and monitor site invitations and feasibility questionnaire for fully funded trials and communicate applicable changes in site participation to COG’s legal/fiscal agent.
• Organize and maintain files and department folders including agendas, minutes, summaries, presentations, agreement, budgets, scopes of work, plans, charters, study related documents, etc.
• Maintain and organize Industry Sponsored Trials tracking logs, deliverables and applicable databases.
• Track and follow-up with sites regarding outstanding Work Orders for fully funded studies and monitor site start-up.
• Liaise with CTEP/CTSU/COG’s legal/fiscal agent and other departments and/or vendors to fulfill necessary requests from industry collaborators.
• Coordinate the review of publications and other study related documents.
• Coordinate the exchange and maintenance of auditing/monitoring documents.
• As needed, assist with onsite visits/audits and other meetings with industry sponsors or regulatory agencies.
• Coordinate drug safety reporting and query communications with industry partners and maintain tracking log.
• Submit agreement requests to COG’s legal/fiscal agents for any new or amended contracts. Submit and respond to inquiries as needed.
• Assist with questions and distribute materials regarding industry-sponsored trials.
• Communicate information on behalf of industry collaborators to COG institutions and/or IST Director.
• Manage monthly grow report distribution to legal/fiscal agent. Investigate and resolve any queries. Maintain accurate records and distribution trackers.
• Assist with Per Case Reimbursement (PCR) and coordinate site payments.
• Assist in requesting internal and external data reports, review to ensure completeness/accuracy and resolve discrepancies as needed.
• Assist in developing and maintaining existing quarterly financial summary reports.
• Assist in creating and distributing accurate invoices and upload files to ensure timely payments to participating sites.
• Assist in preparing excel sheets by institution to support PCR. Format the upload file(s), add in all required site information, finalize, and upload PCR files to the drop payments system.
• Assist in coordinating with PHI and applicable COG individuals to investigate and resolve any payment errors. Resubmit and drop payment files to resolve payment errors.
• Assist in maintaining IST financial trackers and records.
• Assist with working with IT for maintenance and upgrades to the financial database and other systems.
• Establish and maintain standard operating procedures (SOPs) and guides to standardize internal processes related to industry trials.
• At the discretion of the IST Director, assist in other day-to-day operational tasks related to industry-sponsored trials specifically with regard to trial coordination and management.
• Perform other duties as assigned.

Minimum Qualifications

• Three years of related experience as clinical research coordinator, program coordinator or Clinical Research Associate (CRA).
• Bachelor’s degree in science or related field, or substitute with four additional years of related experience.

Other Qualifications

• Project and/or program coordination experience preferred.
• Background in oncology strongly preferred.
• Ability to work accurately, consistently and efficiently on assigned projects; superior prioritization and organization skills.
• Independent, self-directed professional.
• Excellent oral and written communication skills.
• Knowledge of Microsoft Office applications.
• Ability to learn job responsibilities efficiently and quickly.
• Familiarity with scientific terminology.

FAIR LABOR STANDARDS ACT (FLSA) STATUS

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

EEO Statement

The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.

For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

ADA Statement:

The Public Health Institute is committed to providing access and reasonable accommodation in its services, programs, activities and employment for individuals with disabilities. To request disability accommodation in the application process, contact the Recruitment Team at least 48 hours in advance at Recruitment@phi.org.

#LI-REMOTE

To apply for any position, you must create an account on the Public Health Institute’s job application site. After creating your account, you may search the open positions and apply for the specific position that interests you. Please note, mailed and emailed applications will not be accepted.

We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.