Clinical Protocol Coordinator Jobs

Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Rockville, MD.

Overall Position Summary And Objectives

This position will independently provide support services to satisfy the overall operational objectives of the NCI/DCEG

Deliverables

• Work products and documents related to assisting with drafting and maintaining Standard Operating Procedures for all study operations; reporting on metrics of participant recruitment, retention, and follow-up as well as data receipt, completeness, and quality; helping to maintain a project management plan encompassing planning, tracking, execution, and completion of activities for all tasks. - Ad-Hoc
• Work products and documents related to assisting staff with coordination of contracted health care sites, central biorepository, internal IT/data systems development team, and other entities to accomplish core objectives; assisting in development of plans for site visits for training and monitoring project implementation. - Ad-Hoc
• Work products and documents related to assisting with internal information flow within the Division on the study progress, such as updating the Division intranet site and responding to inquiries from investigators; maintaining administrative access rights to the study’s file sharing system; advising on management of all study-related approvals (e.g. IRB). - Ad-Hoc
• Work products and documents related to Work products and documents related to maintaining communications by organizing meetings and teleconferences, agendas and meeting notes, actions items and decision logs, and tracking and responding to issues requiring resolution; coordinating with appropriate Federal staff to order supplies and coordinate delivery to field sites; preparing presentations, reports, and manuscript writing as needed. - Ad-Hoc

Work Details

• Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
• Develops, assembles and reviews clinical trial documents.
• Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Assist researchers develop standard operating procedures (SOPs) for the clinical study. 1
• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Assist staff to establish standardized infrastructure and procedures for recruitment and follow-up while accommodating site-specific requirements.
• Maintain administrative access rights to the study’s file sharing system.
• Provides technical support to researchers and the clinic.
• Assist staff on protocol coordination, including matching and locating control subjects, completing registration phone calls, reviewing study questionnaires and resolving queries with patients.
• Assist with internal information flow within the Division on the study progress, such as updating the Division intranet site and responding to inquiries from investigators.
• Maintains study databases and conducts basic analysis.
• Collects, distributes and files regulatory documents.
• Develops and assembles clinical trial documents.
• Occasional air travel to locations across the U.S. for site visits.
• Assists researchers with protocol development, assembly and review of clinical trial documents.
• Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
• Report on metrics of participant recruitment, retention, and follow-up as well as data receipt, completeness, and quality (i.e. questionnaire and electronic medical records) and biological specimen collection.
• Evaluate and report on metrics of participant recruitment, retention, and follow-up as well as data receipt, completeness, and quality (i.e., questionnaire and electronic medical records) and biological specimen collection 3
• Develops and maintains trial related documents and operational procedures.
• Assist IRB administrator collect, review and maintain all IRB records. 4
• Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports.
• Assists researchers develop and maintain trial related documents and operational procedures.
• Assist staff with coordination of contracted health care sites, central biorepository, internal IT/data systems development team, and other entities to accomplish core objectives. 5
• Coordinate with appropriate Federal staff to order supplies and coordinate delivery to field sites.
• Coordinate and tracks edits to all study related documents
• Prepare new and review completed study reports and status updates, including amendments, audits and other administrative documentation.
• Coordinate with IRB administrator to collect, review and maintain all IRB records.
• Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
• Help to maintain a project management plan encompassing planning, tracking, execution, and completion of activities for all tasks.
• Assists researchers collect, distribute and file regulatory documents.
• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
• Maintain communications by organizing meetings and teleconferences, agendas and meeting notes, actions items and decision logs, and tracking and responding to issues requiring resolution. 2
• Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
• Collects and distributes regulatory documents.
• Assist in development of plans for site visits for training and monitoring project implementation.
• Coordinate with IRB administrator to collect, review and maintain all IRB records.

1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Minimum Education

Master's

Additional Qualifications

Certifications & Licenses

• *Willing to accept candidates both local and remote - max flexibility permissible.
• Master’s degree in Life Sciences or other related discipline

Field of Study

• Miscellaneous Biology
• Health and Medical Administrative Services

Software

• MS Office Suite

Skills

• Experience in government or academic health research
• Experience with PowerPoint, Excel, and flowcharting system such as Visio
• Excellent communication skills (email, written, and verbal)
• Work with a multidisciplinary team with varying skill levels and to liaise with multiple stakeholders
• Highly detail oriented
• Able to work on multiple tasks simultaneously and effectively prioritize work in a fast-paced environment
• Work independently and seek guidance appropriately
• Must demonstrate a history of proven success in study management
• Ability to assist with both routine and/or last-minute projects

Benefits

• Transportation Reimbursement Account (TRN)
• 401K Matching
• Healthcare (FSA)
• Flexible Spending Accounts
• Profit Sharing
• 100% Medical Dental & Vision Coverage for Employees
• Dependent Care Assistant Program (DCAP)
• Employee Referral Bonus
• Paid Time Off (Including Holidays)
• Parking Reimbursement Account (PRK)
• Educational Benefits for Career Growth

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility If you need an accommodation as part of the employment process please contact [email protected]

DisclaimerThe above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.