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Protocol Coordinator

Posting Number: #1103

Position Title: Protocol Coordinator

Closing Date: Until Filled

Location: Remote

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Program Summary

Children’s Oncology Group (COG), a project of PHI, is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.

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 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Europe in the fight against childhood cancer. An overarching principle of COG is to ensure that the organization’s structure is optimized to maximize the potential for research that improves the outcome for every successive generation of children with cancer.

The Protocol Coordinator (PC) serves as the protocol document specialist on the study team (Protocol Coordinator, Research Coordinator, Study Builder and Statistician) for all assigned COG trials. This position is responsible for developing and maintaining clinical research protocols, concepts, site communication memos, study training materials and other study related documents under the scientific direction of the Study Chair and COG/Scientific Committee leadership. This includes managing all internal and external review and approval processes throughout the trial, from early study concept to amendments, and coordinating with fellow team members.

Essential Duties & Responsibilities

Study Development

  • Serve as the protocol document specialist within the study team.
  • Manage the development of all documents relating to clinical research protocols in conjunction with the study chair, study committee, COG scientific committee leadership and the study team.
  • Coordinate all internal and external review and approval processes throughout the length of a trial, from early study concept to study closure.
  • Establish and communicate clear study development goals and deadlines to be met by study chairs, pharmacists, statisticians and others in order to ensure study activation within Operational Efficiency Working Group (OEWG) timelines.
  • Design therapy delivery maps consistent with the treatment plan outlined in the protocol.
  • Maintain internal study records and track important study events through COG tracking applications as outlined in departmental SOPs.
  • Review draft Case Report Forms (CRFs) for consistency with the protocol document and ensure specific requirements of the protocol are met.
  • Deliver a final research document that incorporates all clinical details needed to treat patients and research elements needed to answer study questions.
  • Work with the Web Content Coordinator to prepare e-friendly study documents that contain the appropriate bookmarks and active links for website posting.

Study Management

  • Communicate with and facilitate communication between study chairs, study committee members, scientific committee chairs, institutional CRAs and other cooperative groups as necessary.
  • Work with the study team to respond to and resolve queries. Take the lead on resolving issues relating to study documents.
  • Track information on reported problems regarding consistency and/or clarity in open protocols and work with the study team and study chair to resolve problems and amend the document as necessary.
  • Stay informed of upcoming projects by attending study/disease committee meetings and team/league meetings. Represent COG operations at COG scientific meetings.
  • Perform related duties as required or assigned by the league leadership.

Writing

  • Draft informed consent documents and youth information sheets according to COG guidelines.
  • Maintain standard COG template language sections in protocol documents.
  • Assist with other projects as needed.

 Qualifications

  • Experience in clinical research trials and clinical trial protocol development, including familiarity with clinical trial components such as statistics, study methodology, informed consent, eligibility and adverse events.
  • 2-3 years writing experience involving protocols, published manuscripts, grants or other documents related to scientific research is highly desired.
  • Demonstrated success and skill at researching, analyzing, and evaluating scientific information.
  • Ability to work independently as well as collaboratively with Group staff and investigators.
  • High level of computer literacy, including intermediate to advanced knowledge of Microsoft Word.
  • Excellent verbal and written communications skills.
  • Knowledge of word processing and medical terminology.
  • Clinical Research experience in life sciences or related field is desired.

Education

  • Bachelor’s degree required. Masters in life sciences or related field is preferred.

Important Information

  • This is a full-time (40 hours/week) position.
  • To qualify for this position, applicants must be legally authorized to work in the United States.

PHI WORKFORCE MANDATORY COVID-19 VACCINATION POLICY

Per the PHI Workforce Mandatory COVID-19 Vaccination Policy, effective January 10, 2022, it is a condition of employment for all employees to be fully vaccinated for COVID-19, unless they are granted a reasonable accommodation under applicable law. Employees starting on or before February 28, 2022 will need to provide proof of full vaccination up to 6 weeks after their start date or apply for an exemption/accommodation within three business days after their start date. Employees starting after February 28, 2022 will need to provide proof of full vaccination prior to their start date or apply for an exemption/accommodation within three business days after their start date.  Depending on the circumstances, new hires who do not comply with this Policy, or who cannot be reasonably accommodated, will either have their employment suspended or terminated. Candidates who are non-compliant will have their offers rescinded.

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.

 

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.

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