GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Massachusetts General Hospital Center for Aging and Serious Illness (CASI) is seeking Clinical Research Coordinators to support ongoing clinical research focused on patient-centered and caregiver outcomes and improving the lives of older adults and those with serious illness and their care partners. Our research aims to improve quality of life, well-being, symptom and pain management, and reduce caregiver burden:

For example, a Clinical Research Coordinator to support a large multi-site clinical trial study that focuses on the comparison of care delivery models to support older adults with complex healthcare needs. The team's research is focused on the improvement of patient and caregiver outcomes for high-risk older adults (ages 65 ) with chronic and serious healthcare conditions.

CASI's mission is to better understand the needs of older adults or those living with serious illness and their caregivers, develop new interventions, improve current treatments, and explore new questions at the intersection of aging and serious illness. Our interdisciplinary team is comprised of investigators from various disciplines including medicine, psychology, social work, and physical therapy. Our team conducts a vast array of clinical trial and observational studies in primary care, hospital-based, and community settings.

CRCs support the organization and execution of these research projects and center-wide initiatives. CRCs are responsible for assisting study start-up; recruiting, enrolling, and retaining participants in the study; performing study assessments and follow-ups; data entry and management; and facilitating community outreach and stakeholder engagement. Qualified applicants should be comfortable working in a team-oriented environment with other CRCs, program managers, interventionists, and medical trainees.

Ideal candidates will be self-motivated, attentive to detail, have the capacity to tend to multiple priorities and deadlines, and demonstrate strong interpersonal and organizational skills. Candidates with prior clinical research experience are required. Candidates with prior experience with serious illness, supporting older adults and other vulnerable and minoritized populations, family caregivers and diverse groups are strongly encouraged to apply.

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 departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.

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.

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.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

The candidate should:

1) be well-organized, self-motivated, and attentive to detail;

2) be able to multi-task, problem-solve, function in a fast-paced environment, and manage time/work-load with minimal supervision;

3) have excellent interpersonal communication skills to effectively communicate with a multidisciplinary team and research participants;

4) have the ability to work independently, take initiative, and interact with clients and colleagues of multiple disciplines;

5) cultural sensitivity and humility in working with older adults and stakeholders in community settings;

6) be proficient in using administrative software (Excel, Word, PowerPoint), electronic healthcare records, webpage development, and electronic data capture systems (e.g. REDCap, Qualtrics);

7) demonstrate respect and professionalism for subjects' rights and individual needs;

8) have a working knowledge of clinical research protocols;

9) have analytical skills and the ability to resolve technical problems;

10) have an ability to interpret acceptability of data results; and

11) have a working knowledge of data management programs (e.g. SPSS, SAS).

EDUCATION:

• Bachelor's degree required.
• Experience working in a medical or clinical research setting (e.g. medicine, psychology)

EXPERIENCE:

• New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
• Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
• Spanish language fluency, desirable.

SUPERVISORY RESPONSIBILITY:

• A Clinical Research Coordinator I does not have any supervisory responsibility.
• A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

WORKING CONDITIONS:

Fast paced and dynamic healthcare research institute setting.

Typical work hours are Monday through Friday daytime hours but may vary based upon individual program or event demands - up to and including periodic evenings and weekend days.

MGH Main Campus area, but periodic travel to other Mass General Brigham Healthcare system and non-MGB program locations will be necessary.

This role requires individuals to work predominantly on-site, with telecommuting options available.

The above is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities, or skills of personnel so classified.