Clinical Research Specialist

The Clinical Research Specialist will play a key role in the success of our research program by coordinating and overseeing the implementation of recruitment and other operations activities for multiple, concurrent clinical research studies/trials. This includes strategizing with staff to resolve problems, ensuring uniform application of regulatory requirements, and communicating with internal regulatory agencies such as the IRB and the DSMB.

1. Program Communication:

Develop and maintain systems to monitor the REU's recruitment approaches and techniques, increase visibility of the REU's research studies within and beyond MGH, identify new opportunities to recruit relevant participants, and improve recruitment processes.

1. Protocol Execution and Design:

Recruit study subjects, obtain informed consent, assist in screening participants for study eligibility, review screening data, report noteworthy participant data to the Principal Investigator, coordinate with clinical staff, aid with conduct/completion of study procedures, and perform project-related tasks.

1. Data Management:

Obtain and organize patient data from medical records, physicians, etc., using HIPAA/GCP guidelines, data entry and analysis, conduct library and internet searches, use software programs to generate graphs and reports, contribute to development and maintenance of research data, subject files, and study databases, and assist with formal audits of protocol/INDs.

1. Regulatory Compliance:

Develop and maintain protocol-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions, update and verify accuracy of study forms per protocol, monitor and report adverse events as required by institutional/federal regulations, assist in maintaining regulatory binders for protocols and INDs, facilitate integration of regulatory issues to ensure safe practice, develop and maintain systems for QA/QC, contribute protocol recommendations, and prepare and submit protocols, reports, and regulatory submissions as required by FDA, NIH, IRB, MGH subcommittees.

1. General Support:

Train and orient new study staff, execute all program operations, including drafting or reviewing SOPs, training documents, and workflows, ensure that SOPs are followed, enforce uniform standards for data management across the Unit, order clinical research laboratory supplies and oversee inventories, oversee bio-tissue sample processing, maintain sample collection repository, receive, ship, and store specimens as required by protocol, participate in conference calls and other meetings as directed, and perform other duties and responsibilities at the supervisor's request.

The ideal candidate for this position is energetic, enthusiastic, proactive, and deadline-driven. The Clinical Research Specialist will be a daily point person for the team's clinical research coordinators, helping maintain the best possible team environment. They will be responsible for fostering and enhancing inter-team collaboration, serving as a source of knowledge and expertise for the more junior staff.

The Clinical Research Specialist will focus on ensuring that recruitment of research participants across the REU's research program proceeds on schedule and that daily study operations (research visits and associated tasks) run smoothly. They will also spend a significant amount of time overseeing and prioritizing the activity of clinical research coordinators, informing work flow and assignments of personnel across multiple protocols to ensure the most efficient and effective use of resources.

This will require the ability to respond quickly to unexpected changes and challenges with appropriate speed but also with sophistication of thought. Above all else, this requires appropriate identification of situations where the Program Manager and/or Sr Program Manager need to become involved in designing and implementing solutions.

The Clinical Research Specialist will establish and maintain systems to monitor the REU's recruitment approaches and techniques, increase visibility of the REU's research studies within and beyond MGH, identify new opportunities to recruit relevant participants, and, when indicated by metrics data, improve recruitment processes.

The Clinical Research Specialist will represent the REU in relating to colleagues and collaborators within MGH (including Clinical Trials Pharmacy, the Translational and Clinical Research Center, and Radiology) and beyond.

The Clinical Research Specialist will be responsible for coordinating and overseeing the implementation of recruitment and other operations activities for multiple, concurrent clinical research studies/trials, including strategizing with staff to resolve problems, ensuring uniform application of regulatory requirements, and communicating with internal regulatory agencies such as the IRB and the DSMB.

The Clinical Research Specialist will be responsible for recruiting study subjects, obtaining informed consent, assisting in screening participants for study eligibility, reviewing screening data, reporting noteworthy participant data to the Principal Investigator, coordinating with clinical staff, aiding with conduct/completion of study procedures, and performing project-related tasks.

The Clinical Research Specialist will be responsible for obtaining and organizing patient data from medical records, physicians, etc., using HIPAA/GCP guidelines, data entry and analysis, conducting library and internet searches, using software programs to generate graphs and reports, contributing to development and maintenance of research data, subject files, and study databases, and assisting with formal audits of protocol/INDs.

The Clinical Research Specialist will be responsible for developing and maintaining protocol-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions, updating and verifying accuracy of study forms per protocol, monitoring and reporting adverse events as required by institutional/federal regulations, assisting in maintaining regulatory binders for protocols and INDs, facilitating integration of regulatory issues to ensure safe practice, developing and maintaining systems for QA/QC, contributing protocol recommendations, and preparing and submitting protocols, reports, and regulatory submissions as required by FDA, NIH, IRB, MGH subcommittees.

The Clinical Research Specialist will be responsible for training and orienting new study staff, executing all program operations, including drafting or reviewing SOPs, training documents, and workflows, ensuring that SOPs are followed, enforcing uniform standards for data management across the Unit, ordering clinical research laboratory supplies and overseeing inventories, overseeing bio-tissue sample processing, maintaining sample collection repository, receiving, shipping, and storing specimens as required by protocol, participating in conference calls and other meetings as directed, and performing other duties and responsibilities at the supervisor's request.

The ideal candidate for this position is energetic, enthusiastic, proactive, and deadline-driven. The Clinical Research Specialist will be a daily point person for the team's clinical research coordinators, helping maintain the best possible team environment. They will be responsible for fostering and enhancing inter-team collaboration, serving as a source of knowledge and expertise for the more junior staff.

The Clinical Research Specialist will focus on ensuring that recruitment of research participants across the REU's research program proceeds on schedule and that daily study operations (research visits and associated tasks) run smoothly. They will also spend a significant amount of time overseeing and prioritizing the activity of clinical research coordinators, informing work flow and assignments of personnel across multiple protocols to ensure the most efficient and effective use of resources.

This will require the ability to respond quickly to unexpected changes and challenges with appropriate speed but also with sophistication of thought. Above all else, this requires appropriate identification of situations where the Program Manager and/or Sr Program Manager need to become involved in designing and implementing solutions.

The Clinical Research Specialist will establish and maintain systems to monitor the REU's recruitment approaches and techniques, increase visibility of the REU's research studies within and beyond MGH, identify new opportunities to recruit relevant participants, and, when indicated by metrics data, improve recruitment processes.

The Clinical Research Specialist will represent the REU in relating to colleagues and collaborators within MGH (including Clinical Trials Pharmacy, the Translational and Clinical Research Center, and Radiology) and beyond.

The Clinical Research Specialist will be responsible for coordinating and overseeing the implementation of recruitment and other operations activities for multiple, concurrent clinical research studies/trials, including strategizing with staff to resolve problems, ensuring uniform application of regulatory requirements, and communicating with internal regulatory agencies such as the IRB and the DSMB.

The Clinical Research Specialist will be responsible for recruiting study subjects, obtaining informed consent, assisting in screening participants for study eligibility, reviewing screening data, reporting noteworthy participant data to the Principal Investigator, coordinating with clinical staff, aiding with conduct/completion of study procedures, and performing project-related tasks.

The Clinical Research Specialist will be responsible for obtaining and organizing patient data from medical records, physicians, etc., using HIPAA/GCP guidelines, data entry and analysis, conducting library and internet searches, using software programs to generate graphs and reports, contributing to development and maintenance of research data, subject files, and study databases, and assisting with formal audits of protocol/INDs.

The Clinical Research Specialist will be responsible for developing and maintaining protocol-specific systems for Quality Assurance/Quality Control, IRB amendment and reviews, and external regulatory submissions, updating and verifying accuracy of study forms per protocol, monitoring and reporting adverse events as required by institutional/federal regulations, assisting in maintaining regulatory binders for protocols and INDs, facilitating integration of regulatory issues to ensure safe practice, developing and maintaining systems for QA/QC, contributing protocol recommendations, and preparing and submitting protocols, reports, and regulatory submissions as required by FDA, NIH, IRB, MGH subcommittees.

The Clinical Research Specialist will be responsible for training and orienting new study staff, executing all program operations, including drafting or reviewing SOPs, training documents, and workflows, ensuring that SOPs are followed, enforcing uniform standards for data management across the Unit, ordering clinical research laboratory supplies and overseeing inventories, overseeing bio-tissue sample processing, maintaining sample collection repository, receiving, shipping, and storing specimens as required by protocol, participating in conference calls and other meetings as directed, and performing other duties and responsibilities at the supervisor's request.