Protocol Coordinator

COG Research Foundation, LLC

2h•$64,542 - $92,421•Remote

About The Position

The Protocol Coordinator (PC) serves as the protocol document specialist on the study team for assigned Children’s Oncology Group (COG) trials. Employed through COG Research Foundation, LLC, the PC develops and maintains 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 and Scientific Committee leadership. The role manages internal and external review and approval processes throughout a trial, from early study concept through amendments and closure, and coordinates closely with other study-team members. The position is with a 100% remote employer, although some travel may be required. The employee must reside within the United States. The full salary range is $64,542–$92,421 per year; the typical hiring range is $64,542–$78,482 based on 100% FTE. Starting salary depends on the candidate’s knowledge, skills, experience, and budget availability.

Requirements

Experience in clinical research trials and clinical trial protocol development.
Bachelor’s degree, or four additional years of relevant experience in place of the degree.
Familiarity with clinical trial components such as statistics, study methodology, informed consent, eligibility, and adverse events.
Ability to research, analyze, and evaluate scientific information successfully.
Ability to work independently and collaboratively with Group staff and investigators.
High computer literacy, including intermediate to advanced knowledge of Microsoft Word.
Excellent verbal and written communication skills.
Knowledge of word processing and medical terminology.

Nice To Haves

Two to three years of writing experience involving protocols, published manuscripts, grants, or other scientific research documents is highly desired.
Clinical research experience in life sciences or a related field is desired.
A master’s degree in life sciences or a related field is preferred.

Responsibilities

Serve as the protocol document specialist within the study team.
Manage development of clinical research protocol documents in conjunction with the Study Chair, study committee, COG scientific committee leadership, and study team.
Review supplemental protocol documents, including laboratory manuals, pharmacy manuals, and Electronic Medical Record templates.
Coordinate internal and external review and approval processes throughout a trial, from early study concept to study closure.
Work with the study committee to incorporate protocol changes related to National Coverage Analysis feedback.
Establish and communicate study-development goals and deadlines to study chairs, pharmacists, statisticians, research coordinators, and other committee members to support activation within OEWG timelines.
Manage weekly study-development calls and lead study-development and study-activation kick-off calls.
Design experimental-design schemas and therapy-delivery maps consistent with the protocol treatment plan.
Maintain internal study records and track important study events using COG tracking applications and departmental SOPs.
Work with Research Coordinators to review draft Case Report Forms for consistency with the protocol and ensure protocol requirements are addressed.
Follow PC SOPs for study development and deliver final research documents containing the clinical and research details needed to treat subjects and answer study questions.
Work with League Administrative Assistants to prepare e-friendly study documents with appropriate bookmarks and active links for website posting.
Communicate with and facilitate communication among study chairs, study committee members, scientific committee chairs, institutional CRAs, and other cooperative groups.
Work with the study team to respond to and resolve queries, leading resolution of issues related to study documents.
Track reported problems with consistency or clarity in open protocols and work with the study team, study chairs, and disease chairs to resolve issues and amend documents as necessary.
Identify when website postings are needed to communicate study updates and prepare documents for posting.
Attend study and disease committee meetings and team and League meetings to stay informed about upcoming projects; represent COG operations at COG scientific meetings.
Draft informed consent documents and youth information sheets according to COG guidelines.
Maintain standard COG template-language sections in protocol documents and draft study-specific supplemental documents as needed.
Assist with other projects and perform other duties as assigned.