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 Institute on Drug Abuse (NIDA) located in Baltimore, MD.

Overall Position Summary and Objectives We are requesting a Study Coordinator for full-time laboratory study management and regulatory support for RAPT. The Study Coordinator will perform a variety of research, data, regulatory, and clerical duties of a routine and technical nature to support the conduct of Clinical Human Subjects Research under the direction of senior research team members. The candidate must have excellent interpersonal skills core components of the job are to interact with study participants, work effectively with junior mentees, and liaison with collaborators and administrators both within and outside the Institute.

Deliverables

• Meet with lab members to present updates - Ad-Hoc
• Conduct clinical studies, including collection of human research data, facilitating the execution of clinical protocols, and facilitating the coordination of study procedures across members of the laboratory team and their collaborators, with emphasis on independently guiding junior mentees (such as postbac fellows) in their day-to-day implementation of study requirements. - Ad-Hoc

Work Details

• Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.
• Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
• Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation.
• Assists researchers collect, distribute and file regulatory documents.
• Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies. 4
• Assist with logging and reporting of adverse events.
• Develops and assembles clinical trial documents.
• Review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes.
• Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.
• Assist researchers coordinate recruitment, scheduling, travel and admission of research study participants with clinical staff.
• Develop new and review completed protocol documentation including schemas, patient calendars and teaching aids.
• Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Develops and maintains trial related documents and operational procedures.
• Prepare submission documentation for regulatory bodies in support of clinical trials.
• Prepare new and review completed study reports and status updates, including amendments, audits and other administrative documentation.
• Review completed clinical research informed consent and other ethics and regulatory related documentation and recommend changes.
• Maintain a schedule of all submission deadline dates and meeting dates for all active studies and INDs/IDEs on behalf of the PI per protocol.
• Review completed protocol documentation including schemas, patient calendars and teaching aids and recommend changes.
• Develops training plans and trains staff on the proper techniques for protocol submission.
• Assist researchers screen study participants and document results of screenings.
• Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Maintains study databases and conducts basic analysis.
• Understand the requirements related to good clinical practice (GCP) and support the team in developing and maintaining required regulatory documents and files.
• Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals and others.
• Review completed study reports and status updates, including amendments, audits and other administrative documentation and recommend changes.
• Assist staff on onsite and offsite patient scheduling issues and processes, form preparation, etc. 1
• Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
• Develops, assembles and reviews clinical trial documents.
• Develop new and review completed standard operating procedures (SOPs) for the clinical study.
• When applicable, assist with Annual Report submissions and ongoing communications with the FDA as well as reports and ongoing communications with the Data Safety and Monitoring Board (DSMB).
• Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
• Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
• Maintain data files within multiple software systems, including computerized procurement reports and communication programs.
• Coordinate submission of protocols for review by scientific review committee(s), the IRB, and, when applicable, the clinical-trial sponsor or the FDA. Monitor those review processes and maintain detailed, complete, and accurate records for each protocol of approvals, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events, in coordination with ORSC.
• Review records of all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness.
• Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.
• Reviews and recommends changes to clinical trial documents.
• Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems and concerns to appropriate staff members. 2
• Develop clinical research informed consent and other ethics and regulatory related documentation.
• Develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Develop internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
• Assist with all activities related to protocol documentation, including preparation for the submission of initial protocol documents and consent forms, submission of protocol amendments, problem reports and adverse events, continuing reviews, etc., to the Institutional Review Board (IRB) of record and the Office of Research Support and Compliance (ORSC).
• Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
• Review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts and recommend changes.
• Develop standard operating procedures (SOPs) for the clinical study.
• Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Assists researchers with protocol development, assembly and review of clinical trial documents.
• Develop protocol documentation including schemas, patient calendars and teaching aids.
• Follow NIDA SOPs and NIH policies and regulations 5
• Perform periodic quality reviews to verify that regulatory requirements are being met.
• Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Prepare researcher communication with IRB and NIH Clinical Center for protocol approval.
• Assist staff on protocol coordination, including matching and locating control subjects, completing registration phone calls, reviewing study questionnaires and resolving queries with patients.
• Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Review for accuracy and completeness adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
• Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms. 3
• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
• Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
• 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.
• Provides technical support to researchers and the clinic.
• Assist researchers prepare, review and submit clinical data to monitoring agencies.
• Maintain a schedule of all submission deadline dates and meeting dates for all active studies and INDs/IDEs on behalf of the PI per protocol
• Collects and distributes regulatory documents.
• Prepare study reports and status updates, including amendments, audits and other administrative documentation.
• Collects, distributes and files regulatory documents.
• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Perform entry and cleanup of study of the questionnaire data in various databases, and conduct queries to answer researcher questions.
• Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Review for accuracy and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Prepare and submit documentation for regulatory bodies in support of clinical trials.
• Communicate with IRB and NIH Clinical Center for protocol approval.
• Reviews and maintains trial related documents and operational procedures.
• Assist researchers develop standard operating procedures (SOPs) for the clinical study.
• Assists researchers develop and maintain trial related documents and operational procedures.
• Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness.
• Review completed standard operating procedures (SOPs) for the clinical study and recommend changes.
• Collects, distributes and submits regulatory documents.
• Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
• Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• 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 and review for accuracy and completeness.
• Perform descriptive statistics and univariate analyses on study data.

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

• Candidate should have training, experience, and/or certification in GCP documentation and/or IRB practices. Active membership to an accredited Clinical Research Organization is desirable, e.g., The Society of Clinical Research Associates (SOCRA), The Public Responsibility in Medicine and Research (PRIMR).
• Candidate must possess a bachelor’s degree in Health Science + 1 years’ experience in Clinical Research. A Master’s degree (Psychology, Social Work, Nursing, or other Allied Health Profession) preferred but not required.

Field of Study

• Miscellaneous Health Medical Professions

Software

• MS Office Suite

Skills

• Statistical Analysis
• Draft reports to IRB and OCD as needed, and follow up as needed - Understand the regulatory requirements for problem reporting, adverse events, and protocol deviations.
• Candidate should possess excellent and proven oral and written scientific communication skills and must be proficient with technology and database management.
• Site monitoring
• Clinical Research
• Coordinating project meetings
• ICH/GCP
• Research
• Data Monitoring
• Scheduling
• Regulatory compliance
• SOPs
• Clinical Trials
• Patient confidentiality
• Data Integrity
• Electronic medical records
• Protocol review revision
• Candidate must have excellent interpersonal skills, because core components of the job are to interact with study participants, work effectively with junior mentees such as postbacs, and liaison with collaborators and administrators both within and outside the Institute.

Benefits

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

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]

Disclaimer The 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.