What are the responsibilities and job description for the Senior Clinical Research Coordinator position at Massachusetts General Hospital?
Clinical Trial Responsibilities
- Manage study operations and ensure integrity of study
- Facilitate IRB submission process by preparing protocol applications, protocol amendments, safety reports, and other required documents.
- Manage and maintain regulatory documents for audit by sponsor or FDA.
- Assist recruitment and/or randomization of subjects per study protocol
- Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol
- Assess subject's health through interviews; take subjects vital signs
- Perform phlebotomy (if certified) on subjects; process and ship specimens
- Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject's primary care provider
- Maintain subject charts and other data per the protocol and assess data for quality and completeness
- Conduct ongoing review of study progress and provide investigators with progress reports
- Coordinate and facilitate site sponsor visits
Skills/Abilities/Competencies Required:
* Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results
* Highly motivated, self-directed and driven to meet study goals
* Excellent communication skills and willing to assume study leadership role
* Ability to manage time independently, effectively and efficiently
* Ability to juggle multiple tasks, people and schedules.
* High degree of computer literacy, knowledge of Microsoft Office suite
* Ability to demonstrate professionalism and respect for subjects' rights and individual needs
* Must have the ability to prepare and monitor budgets, to identify problems and develop solutions, prioritize tasks and set deadlines.
Experience:
- Minimum 3-5 years full time research experience in a clinical setting required. Experience in investigation drug studies strongly preferred.
- Minimum 1 year of industry sponsored clinical trial experience and IND application experience required.
- Biology and/or laboratory science background preferred, but not required
- Biostatistics background preferred, but not required
Supervisory Responsibilities:
This position may have oversight of other CRC I/IIs as needed. This could include assistance with the orientation and training of new coordinators, under direction of the PI.
Fiscal Responsibility:
Study coordinator will be responsible for submitting and tracking sponsor invoices for milestone payments. In coordination with the research grant manager, CRC will review and reconcile study funds against invoices and follow-up on outstanding payments. CRC will also allocate patient bills to clinical trial funds.
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%)
The General Hospital Corporation is an Equal Opportunity 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.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
