Senior Clinical Research Coordinator, MGH Center for Aging and Serious Illness (CASI)

Principal Duties and Responsibilities: Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon Center needs. Similarly, it is not intended to be construed as an exhaustive statement of all duties, responsibilities, or skills of personnel so classified.

Study Start-Up:

• Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.
• Assist with creation and editing of study documents, such as protocols, consent forms, and subject communications.

Study Maintenance and Regulatory Compliance:

• Recruitment, enrollment, consent, and tracking of participants.
• Collect and organize participant data.
• Assist with preparation of annual review documents and progress reports.
• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
• Verify accuracy of study forms.
• Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
• Documents patient visits and procedures.
• Designs research protocols in conjunction with PI
• Acts as a liaison between study teams and Human Research Affairs
• Recommends protocol changes and submits adverse events

Program Management:

• May coordinate multi-site trials coordinators in conjunction with Program Manager/Director

Quality Assurance:

• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
• Prepares data for analysis and data entry.

Administrative Support:

• Performs varied administrative support duties as required.
• Communicates professionally and effectively with internal and external study collaborators, including investigators, sponsors, and monitors.
• Plans and coordinates trainings and/or conference calls with external collaborators.
• Conducts literature searches.
• Assists PI to prepare complete study reports.
• Assists Investigators with the preparation of posters and analyses for publication.

Grant Administration:

• May design budgets in conjunction with the center Grant Administrator
• May draft annual reports to sponsors and stakeholders in conjunction with PI

Supervisory Responsibility:

• A Senior Clinical Research Coordinator may train, orient, and address competency of staff, interns, and volunteers

Skills / Abilities / Competencies:

The candidate should:

• be well-organized, self-motivated, and attentive to detail;
• be able to multi-task, problem-solve, function in a fast-paced environment, and manage time/work-load with minimal supervision;
• have excellent interpersonal communication skills to effectively communicate with a multidisciplinary team and research participants;
• have the ability to work independently, take initiative, and interact with clients and colleagues of multiple disciplines;
• cultural sensitivity and humility in working with older adults and stakeholders in community settings;
• be proficient in using administrative software (Excel, Word, PowerPoint), electronic healthcare records, webpage development, and electronic data capture systems (e.g. REDCap, Qualtrics);
• demonstrate respect and professionalism for subjects' rights and individual needs;
• have a working knowledge of clinical research protocols;
• have analytical skills and the ability to resolve technical problems;
• have an ability to interpret acceptability of data results; and,
• have a working knowledge of data management programs (e.g. SPSS, SAS).

Sr Clinical Research Coordinators are expected work very independently. The Sr CRC may train, orient, and address competency of staff, interns, and volunteers.

Education:

• Bachelor's degree required. Master's degree or 3-5 years of related experience preferred.
• Experience working in a medical or clinical research setting (e.g. medicine, psychology, social work, public health)

Experience:

• Spanish language fluency is desirable.