On-site Research Program Manager, Ophthalmology

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Location: Burlington, MA
Job ID: 170664-1A
Date Posted: Jun 8, 2022
Category: Clinical Professional

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Job Description

Welcome To

Welcome to Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. Lahey Hospital & Medical Center is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. Lahey also helps to advance medicine through research and the education of tomorrow's health care leaders.

About the Job

Under the direction of the Director of Ophthalmic Research, the Research Program Manager will be responsible for the managing, promoting, cultivating and overseeing all aspects of the ophthalmology clinical research program, including the administration of assigned clinical trials, industry sponsored studies, and bioinformatic research work designed to improve the quality and equity of care delivered by the department. Examples of ongoing studies including phase II/III drug development trials, multi-center sample collection studies, and survey/screening studies designed to improve the detection and monitoring of blinding eye diseases.

Essential Duties & Responsibilities, including but not limited to: 

Successfully completes new coordinator orientation, required training, and mandatory education. 

Implements assigned research studies by reviewing study and assessing protocol and institutional requirements:

  • Implements all study protocols in accordance with Research SOPs, FDA, OHRP, and GCP regulations
  • Prepares, completes and submits start up IRB documents (e.g. informed consents) in a timely manner with some assistance/guidance from senior staff. 

Conducts assigned research studies per protocol requirements, departmental and institutional policy:

  • Creates and/or maintains eRegulatory, patient study and CRF files.
  • Responsible for ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
  • Administers questionnaires and assessments as mandated by the protocol and delegated by the PI.
  • Directly retrieves and/or coordinates the retrieval and submission of patient samples
  • Utilizes current systems to schedule tests and appointments and to access patient data and test results. 

Recruits patients to assigned research studies:

  • Screen subjects to identify potential research subjects and contact them by mail and/or phone
  • Participates in the informed consent process; obtains subjects signatures and processes appropriately per research policies
  • Interview, tracking, and serving as a point of contact for patients and clinical research subjects. 

Performs Data Management duties:

  • Prepares for each study participant visit to ensure all appropriate study procedures are done per protocol; ensures patient visit/test is billed correctly to either insurance or the research account per schema.
  • Evaluate research data and record results, organize and collate data and perform basic tabulations or statistical analyses (training provided)
  • Ensures proper placement of consent and related study materials in EMR system.
  • Maintains study supplies and reorders as necessary. 

Responsible for coordinating different phases of research studies with varying degrees of complexity with moderate oversight.

  • Conduct procedures based on methods either published or routinely used in ophthalmology, e.g. fundus photography, optical coherence imaging, dark adaptation testing.
  • Participates in reporting experimental results and writing research papers
  • Monitor daily research activities including quality control, safety, and compliance within Lahey Clinic Policies.

Performs all other duties as assigned by the Chair and Director of Ophthalmic Research.
 
Minimum Qualifications:
• Education: Master’s degree required. -or- Bachelor’s degree and CCRP/CCRC certification (or equivalent certification) required.
• Licensure, Certification & Registration: CCRP/CCRC certification or equivalent certification required in the absence of a Master’s degree.
• Experience: 3+ years direct work related experience in a research setting; leadership and project management experience required; Epic experience a plus.
 
Skills, Knowledge & Abilities:     
• Ability to make decisions with significant, broad implications for the management of a major department or multiple departments;
• Ability to function independently to set goals and priorities, take initiative and make decisions that are guided by general instructions and practices requiring some interpretation;
• Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observations, knowledge and skills based on general precedents;
• Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations;
• Strong verbal and written communication, multi-tasking, attention to detail and organizational skills;
• Ability to interact with professional personnel at all levels of an organization, communicate clearly and effectively and work collaboratively in small teams;
• Ability to demonstrate a positive and respectful attitude using skills in active listening and problem solving;
• Experience with computer systems, including web based applications required;
In the absence of any of these skills, demonstrates the ability to be thoroughly trained to meet organizational standards.
 
Organizational Requirements:

  • Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy.
  • Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities.
  • Comply with all Lahey Hospital and Medical Center Policies.
  • Comply with behavioral expectations of the department and Lahey Hospital and Medical Center.
  • Maintain courteous and effective interactions with colleagues and patients.
  • Demonstrate an understanding of the job description, performance expectations, and competency assessment.
  • Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
  • Participate in departmental and/or interdepartmental quality improvement activities. 
  • Participate in and successfully completes Mandatory Education.
  • Perform all other duties as needed or directed to meet the needs of the department.

Shift

40 Hours / Day

About Us

Beth Israel Lahey Health is dedicated to improving health and wellness and making a difference in the lives of our patients, their families and all members of the communities we serve.  Formed in March 2019, Beth Israel Lahey Health is a patient-centered, integrated care delivery system providing a continuum of services spanning academic, tertiary and community hospitals, dedicated orthopedic and psychiatric hospitals, primary and specialty care, community acute care, ambulatory care, behavioral services and home health.  Beth Israel Lahey Health Performance Network is a unified joint contracting and population health management organization, jointly governed by participating physicians and hospitals.

Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.