Senior Clinical Research Associate - Protocols & Trials

Global Solutions Network, Inc.; Bethesda (MD); On-site; USD 78,000 - 149,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401K/Profit sharing

Flexible Spending Accounts

Parking plan

Disability Insurance

Life Insurance

Professional Development

Employee Referral Bonuses

Employee Discount Program

Merit Bonuses

Employee Assistance Program

Travel Assistance Program

Job summary

Global Solutions Network, Inc. (GSN) seeks a Senior Research Associate (Clinical) to support NIH, Bethesda, MD on a full-time, long-term basis.

The role involves developing and coordinating protocols, IRB documentation, and regulatory submissions, with extensive collaboration across regulatory bodies. You will assist with study proposals, consent forms, protocol amendments, data management, and QA activities in preparation for audits, while liaising with NIH and FDA stakeholders.

Qualifications

• Master's degree in a related field.
• CITI certification.
• Familiarity with Electronic Data Capture Systems.
• Experience liaising with regulatory authorities.
• Experience training clinical trial site staff.
• Experience coordinating project meetings.
• Experience with previous clinical trial work.

Responsibilities

• Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
• Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
• Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
• Maintain data files within multiple software systems, including computerized procurement reports and communication programs.
• Perform entry and cleanup of study of the questionnaire data in various databases, and conduct queries to answer researcher questions.
• Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
• Assist IRB administrator collect, review and maintain all IRB records.
• Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Organize quality assurance activities with pertinent regulatory bodies such as the FDA, NIH, pharmaceuticals and others.
• Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
• Assist staff on onsite and offsite patient scheduling issues and processes, form preparation, etc.
• Assist researchers coordinate recruitment, scheduling, travel and admission of research study participants with clinical staff.
• Assist researchers screen study participants and document results of screenings.
• Develop internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Develop protocol documentation including schemas, patient calendars and teaching aids.
• Develop clinical research informed consent and other ethics and regulatory related documentation.
• Develop standard operating procedures (SOPs) for the clinical study.
• Prepare study reports and status updates, including amendments, audits and other administrative documentation.
• Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
• Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.
• Coordinate with IRB administrator to collect, review and maintain all IRB records.
• Review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Develop new and review completed protocol documentation including schemas, patient calendars and teaching aids.
• Coordinate with IRB administrator to collect, review and maintain all IRB records.
• Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
• Communicate with IRB and NIH Clinical Center for protocol approval.
• Prepare and submit documentation for regulatory bodies in support of clinical trials.
• Review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts and recommend changes.
• Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.
• Review records of all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness.
• Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness.
• 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.
• Coordinate with IRB administrator to collect, review and maintain all IRBrecords.
• Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
• Communicate with IRB and NIH Clinical Center for protocol approval.
• Coordinate education and guidance regarding research activities, procedures and standards for new staff members.
• Maintain documentation of clinical research training of staff.
• Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
• Educate and train investigators in new protocol management systems; maintain a smooth flow in process for IRB submissions.
• Meet with investigators and advise them of the documentation and approvals they will need to initiate a clinical study based on thetype, location and complexity of the proposal.

Skills

Liaising with regulatory authorities

Training trial site staff

Coordinating project meetings

Previous clinical trial work

Education

Master's degree in a related field

Tools

Electronic Data Capture Systems

Job description

Global Solutions Network, Inc. (GSN) seeks a Senior Research Associate (Clinical) to support NIH, Bethesda, MD on a full-time, long-term basis.

The role involves developing and coordinating protocols, IRB documentation, and regulatory submissions, with extensive collaboration across regulatory bodies. You will assist with study proposals, consent forms, protocol amendments, data management, and QA activities in preparation for audits, while liaising with NIH and FDA stakeholders.