Protocol Coordinator

Position Summary

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 and 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.
• Review supplemental protocol documents, including lab manuals, pharmacy manuals, and Electronic Medical Record templates.
• Coordinate all internal and external review and approval processes throughout the length of a trial, from early study concept to study closure.
• Work with the study committee to ensure protocol changes related to National Coverage Analysis feedback is appropriately incorporated.
• Establish and communicate clear study development goals and deadlines to be met by study chairs, pharmacists, statisticians, research coordinators, and other members of the study committee in order to ensure study activation within Operational Efficiency Working Group (OEWG) timelines.
• Manage weekly study development calls with the study committee to facilitate protocol development discussion and lead study development and study activation kick-off calls.
• Design experimental design schemas and therapy delivery maps consistent with the treatment plan outlined in the protocol.
• Maintain internal study records in study folders and track important study events through COG tracking applications as outlined in departmental SOPs.
• Work with team Research Coordinators to review draft Case Report Forms (CRFs) for consistency with the protocol document and ensure specific requirements of the protocol are met.
• Follow all steps of PC SOPs regarding study development and deliver a final research document that incorporates all clinical details needed to treat subjects and research elements needed to answer study questions.
• Work with the League Administrative Assistants 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, study chairs, and disease chairs to resolve problems and amend the document as necessary.
• Identify the need for website postings to communicate updates for studies and prepare documents to be posted.
• 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.
• Draft study-specific supplemental documents as needed.
• Assist with other projects as needed.
• Perform other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Minimum Qualifications

• Experience in clinical research trials and clinical trial protocol development.
• Bachelor's degree is required, or substitute with four (4) additional years of relevant experience.

Other Qualifications

• Familiarity with clinical trial components such as statistics, study methodology, informed consent, eligibility, and adverse events.
• 2-3 years of writing experience involving protocols, published manuscripts, grants or other documents related to scientific research is highly desired.
• Clinical research experience in life sciences or related field is 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.

Preferred Qualifications

Masters in life sciences or related field is preferred.