Clinical Research Coordinator 1 MGH ACTG at Partner's Healthcare in Boston, Massachusetts

Job Description:

Site: The General Hospital Corporation


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.


TITLE: Clinical Research Coordinator 1


Department: HIV Research/ Dept of Infectious Disease


Overview:
The MGH ACTG clinical research site is seeking an organized and energetic Clinical Research Coordinator (CRC) to assist in the implementation of research protocols focused primarily on HIV. ACTG is a global clinical trials network that conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. The Clinical Research Coordinator I (CRC) will work at the ACTG site of the Infectious Disease Unit of Massachusetts General Hospital to assist and coordinate a variety of duties related to clinical research. The CRC will coordinate data collection, data entry and maintenance of case report forms. In addition, this person will assist with preparing Institutional Review Board (IRB) applications for new studies and amendments for current studies. The CRC will update and create research recruitment materials and will perform chart reviews to assist in identifying eligible study candidates. The CRC will approach and engage with potential study participants to provide information and recruitment materials of enrolling clinical trials. The CRC will work closely with the study staff for optimal unit and study implementation. We are seeking a candidate who is mission-driven, intellectually curious, possesses excellent communication skills and has meticulous attention to detail. Sense of humor is a must.


Principal Duties and Responsibilities:


Coordinates research data activities:
• Ensure compliance with research protocols. Complete, review, and/or audit case report forms for completion and accuracy with source documents.
• Performs quality assurance on data collection
• Enters data using a variety of data bases
• Responds to data queries


Recruitment of patients for clinical research studies:
• Reviews patient charts and identifies potential study subjects based on study specific inclusion/exclusion criteria
• Assists in developing study recruitment strategies including preparing outreach study materials such as web sites, advertisements, fliers etc.
• Interfaces with potential study participants and their clinicians to promote clinical trials and research
• Collaborates with community groups and health care centers to promote diversity, equity, and inclusion in clinical research


Assists study staff with study implementation:
• Prepare materials for study visits
• Monitor and assist with the scheduling of study procedures
• Manages the composition of the source documents, Case Report Forms and other study related materials
• Assists with various study visit procedures as necessary which may include questionnaire administration, phlebotomy, and ECG collection
• Escort study participants to required study tests which may include CT scans, PET scan and Pulmonary Function Testing


Assists in general research and office activities
• Assists with telephone communication including answering the phone, evening phone recording and retrieving messages
• Communicates frequently with ACTG staff to assess research clinic needs which could include going to the pharmacy, laboratories, escorting patients to test areas etc.
• Manages the retrieval and distribution of relevant mail
• Maintains general office supplies to include photocopier, fax machine, printers etc.
• Preparation of other research items which could include case report form preparation, specimen form updates, photocopying and updating files


Coordinates regulatory submissions and correspondence:
• Prepares applications for Translational Clinic Research Center (TCRC)
• Prepares IRB application/submissions for new studies and amendments for current studies
• Maintains regulatory files that include consent forms, eligibility checklists etc.
• Participates in regulatory audits


Competencies Required:
• Proficiency with Microsoft Office including outlook, word and excel. Facility in learning new software applications.
• Good understanding of medical terminology
• Excellent written and verbal communication skills
• Ability to communicate effectively with staff and study participants
• High degree of organizational skills
• Superior Attention to detail
• Flexibility and adaptability
• Intellectual independence, initiative, and problem-solving capabilities
• Ability to work independently and as part of a team
• Ability to read, write and speak Spanish proficiently is valued
• A two-year commitment is preferred


Qualifications:
• Bachelor's degree required
• Knowledge of clinical research principles and regulations preferred
• Ability to handle a variety of tasks amid shifting priorities.



Job Summary
Summary
Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study.


Does this position require Patient Care?
No


Essential Functions
-Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met.


-Recruiting patients for clinical trials, conducts phone.


-Verifies the accuracy of study forms and updates them per protocol.


-Prepares data for analysis and data entry.


-Documents patient visits and procedures.


-Assists with regulatory binders and QA/QC Procedures.


-Assists with interviewing study subjects.


-Assists with study regulator submissions.



Qualifications


Education
Bachelor's Degree Science required


Can this role accept experience in lieu of a degree?
Yes


Licenses and Credentials


Experience
Some relevant research project work 0-1 year preferred


Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.



Additional Job Details (if applicable)



Physical Requirements

• Standing Frequently (34-66%)


• Walking Frequently (34-66%)


• Sitting Occasionally (3-33%)


• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)


• Carrying Frequently (34-66%) 20lbs - 35lbs


• Pushing Occasionally (3-33%)


• Pulling Occasionally (3-33%)


• Climbing Rarely (Less than 2%)


• Balancing Frequently (34-66%)


• Stooping Occasionally (3-33%)


• Kneeling Occasionally (3-33%)


• Crouching Occasionally (3-33%)


• Crawling Rarely (Less than 2%)


• Reaching Frequently (34-66%)


• Gross Manipulation (Handling) Frequently (34-66%)


• Fine Manipulation (Fingering) Frequently (34-66%)


• Feeling Constantly (67-100%)


• Foot Use Rarely (Less than 2%)


• Vision - Far Constantly (67-100%)


• Vision - Near Constantly (67-100%)


• Talking Constantly (67-100%)


• Hearing Constantly (67-100%)

Remote Type


Onsite



Work Location


100 Blossom Street



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


The General Hospital Corporation is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.



Mass General Brigham Competency Framework


At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Apply Now