Children’s Oncology Group (COG), a project of Public Health Institute (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.
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. S/he 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
- 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
- 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.
- 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.
- Bachelor’s degree.
- 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.
- 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 communication skills.
- Knowledge of word processing and medical terminology.
- Master’s degree in life sciences or related field.
- Clinical Research experience in life sciences or related field is desired.
- 2-3 years of writing experience involving protocols, published manuscripts, grants, or other documents related to scientific research is highly desired.
- 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.