Boston, Massachusetts

The Senior Clinical Research Coordinator will work independently and have responsibility for oversight and management of a portfolio of clinical research projects in the Manstein Lab. They will assist in clinical trial planning, submission, coordination, and implementation of clinical research projects. They are expected to collaborate closely with the Program Manager, PI's, and other members of the clinical research team. Under the general supervision of the Principal Investigator, the SCRC will manage all clinical projects (currently approximately 8-10 active studies) in the PI's portfolio in planning and implementing study procedures, coordinating the screening and recruitment of study patients, creating data collection tools, and collecting and maintaining study data. The SCRC will also supervise the other Clinical Research Coordinators (CRCs) within the team and will serve as a resource for teaching other personnel about clinical trials and protocols. In their capacity as the SCRC, they identify and recruit eligible subjects, collect, compile, tabulate and analyze data for the principal investigator, and coordinate related patient care activities in the inpatient and outpatient setting. Present study findings to interested groups both inside and outside of the hospital. Coordinate and implement the research study according to the study protocol. Collaborate with the principal investigator on an ongoing basis regarding progress of the study and the continuation or termination of study subjects. Work with physicians, nurses and subjects in the selection of and participation by appropriate subjects. Obtains all necessary approvals and informed consent forms; screen and enroll subjects into the study. Assess subject participation on a continuous basis in light of ethical considerations. Act as liaison between subject and other members of the team regarding subject care activities relating to the research protocol Individuals in this position must possess strong collaboration skills and the ability to work with physicians and researchers across the hospital to develop and execute clinically relevant research protocols for advancing the field of academic medicine. PRINCIPAL DUTIES AND RESPONSIBILITIES: Clinical study design, amendment, and submission with PI Active role in subject consent process and independently judges suitability of research subjects Acts as liaison between IRB, Research Affairs, and lab Files Adverse Events and Other Events with the IRB Creating and maintaining records at clinicaltrials.gov Develop study budgets Plans, performs, and designs statistical analyses Major role in drafting manuscripts and submissions for publication Develops and implements recruitment strategies Acts as study resource for subjects Responsible for maintaining study binders, quality assurance, and data analysis Organizing research collaborations with active clinical units at MGH Engages in periodic literature reviews Performs allowable clinical research procedures (e.g. blood draw, biopsy, dermatologic procedures as allowed by licensing/hospital regulations) Supervises junior clinical research staff Qualifications SKILLS/ABILITIES/COMPETENCIES REQUIRED: Ability to design, prepare, deliver and evaluate clinical research programs Maintains research study protocols and data records Ability to analyze data and present results High level time management and organizational skills Excellent written and verbal communication skills Administrative skills to meet regulatory requirements Ability to prepare/monitor budgets Knowledge of current and developing clinical research trends Ability to meet the requirements of varying funding sources Sound interpersonal skills and the ability to supervise others Ability to work independently and display initiative to introduce innovations to research study Ability to identify problems and develop solutions Ability to supervise junior clinical research staff LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): N/A EDUCATION: BA/BS Required, MA/MS/MPH Preferred EXPERIENCE: Minimum of 3-5 years of directly related research experience. SUPERVISORY RESPONSIBILITY (if applicable): Overseeing the training, orientation, education, and address the competency of staff, interns, and volunteers. Training new CRC and transitioning clinical investigators on ongoing studies. FISCAL RESPONSIBILITY (if applicable): The SCRC will be responsible for periodically auditing payments to research participants and ensure the timely receipt of stipends. Furthermore, they will be responsible for providing budget estimates and monitoring budgets for proposed and ongoing studies in both clinical and translational research. WORKING CONDITIONS: The SCRC will work in a clinical research setting. EEO Statement 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.Partner's Healthcare is acting as an Employment Agency in relation to this vacancy.

Boston, Massachusetts

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