clinical research coordinator i

clinical research coordinator ii Jobs in Boston

clinical research coordinator ii

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adjunct faculty - healthcare informatics

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administrative coordinator

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associate director regulatory affairs cmc and devices

CVS Health

<div>We&rsquo;re building a world of health around every individual &mdash; shaping a more connected, convenient and compassionate health experience. At CVS Health&reg;, you&rsquo;ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger &ndash; helping to simplify health care one person, one family and one community at a time.
Position Summary
Reporting to the Executive Director of Revenue Integrity (RI), the Lead Director &ndash; Revenue Integrity (Medicaid) is responsible for driving segment-level performance across Medicaid risk adjustment and revenue integrity initiatives. This role leads strategic program execution, performance management, and data-driven decision-making to ensure complete, accurate, and compliant revenue capture in a highly matrixed environment.
As a senior leader within the Revenue Integrity Center of Excellence (RI CoE), this role partners closely with enterprise, regional, and market stakeholders to identify performance risks, implement scalable solutions, and improve outcomes across Medicaid markets. The Lead Director plays a critical role in advancing performance office governance, optimizing program effectiveness, and ensuring alignment with enterprise revenue integrity strategy.
This position requires a results-oriented leader with deep Medicaid expertise, strong analytical capabilities, and the ability to drive cross-functional alignment in a complex, regulated environment.
Key Responsibilities
1. Program Leadership &amp; Governance (45%)<ul><li>
Lead executive and performance governance forums to proactively identify risks and performance gaps impacting revenue integrity outcomes.</li><li>
Design, implement, and continuously refine national Medicaid RI programs aligned to enterprise strategy and regulatory requirements.</li><li>
Partner with RI CoE leaders, clinical leadership, and network organizations to strengthen program effectiveness and drive measurable outcomes.</li><li>
Establish scalable processes, workflows, and operational frameworks to support program execution and sustainability.</li><li>
Lead and deliver high-impact strategic initiatives that improve revenue accuracy, compliance, and overall performance.</li></ul>
2. Performance Analytics &amp; Reporting (20%)<ul><li>
Partner with Informatics, Technology, and Performance Office teams to develop and operationalize robust performance reporting.</li><li>
Define and monitor key performance indicators (KPIs), leading indicators, and dashboards to drive actionable insights.</li><li>
Synthesize complex data into executive-level insights and recommendations.</li><li>
Ensure data integrity, reporting accuracy, and alignment across systems supporting Medicaid revenue integrity programs.</li></ul>
3. Market Strategy &amp; Performance (25%)<ul><li>
Provide strategic leadership and oversight of Medicaid market performance across regions.</li><li>
Collaborate with regional and local leaders to identify risks, remove barriers, and implement targeted interventions.</li><li>
Serve as a trusted advisor to market leadership, driving accountability for revenue integrity performance.</li><li>
Champion adoption of enterprise programs while tailoring strategies to local market dynamics.</li></ul>
4. Talent Leadership &amp; Organizational Development (10%)<ul><li>
Lead and develop a high-performing team with clear accountability for outcomes.</li><li>
Set performance expectations aligned with enterprise objectives and foster a culture of continuous improvement and innovation.</li><li>
Coach and mentor team members to build strategic, analytical, and leadership capabilities.</li></ul> 
Required Qualifications<ul><li>
A minimum of 10 years of experience in Medicaid risk adjustment / revenue integrity.</li><li>
Demonstrated expertise in Medicaid regulatory requirements, including risk adjustment methodologies and encounter data processes.</li><li>
Proven ability to develop and execute strategic initiatives that deliver measurable business outcomes.</li><li>
Strong leadership capabilities with advanced problem-solving and decision-making skills in complex, matrixed environments.</li><li>
Experience leading large-scale, cross-functional programs with significant enterprise-wide impact.</li><li>
Skilled at influencing senior stakeholders and driving change within highly regulated environments.</li><li>
Consistent attendance and flexibility to travel as required.</li></ul> 
Preferred Qualifications<ul><li>
Master&rsquo;s degree (e.g., MBA, MPH) or completion of a management development program.</li><li>
Deep understanding of enterprise Medicaid markets and state-specific regulatory environments.</li><li>
Experience working within a large national health plan or payer organization.</li><li>
Prior experience in a highly matrixed, enterprise-scale organization.</li></ul> 
Education<ul><li>
Bachelor's degree preferred or a combination of professional work experience and education.</li></ul>
Pay Range
The typical pay range for this role is:
$100,000.00 - $231,540.00 
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above. This position also includes an award target in the company&rsquo;s equity award program. 
Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.
Great benefits for great people
We take pride in offering a comprehensive and competitive mix of pay and benefits that reflects our commitment to our colleagues and their families. 
This full‑time position is eligible for a comprehensive benefits package designed to support the physical, emotional, and financial well‑being of colleagues and their families. The benefits for this position include medical, dental, and vision coverage, paid time off, retirement savings options, wellness programs, and other resources, based on eligibility. 
Additional details about available benefits are provided during the application process and on Benefits Moments. 
We anticipate the application window for this opening will close on: 06/27/2026
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.</div>

Medicaid Risk Adjustment Program Management Lead Director

Dana-Farber Cancer Institute

<div>The CRC (Clinical Research Coordinators) work within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Research Manager. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions. This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required. 
 
This position is considering 2026 bachelor's degree graduates.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.<ul><li> 
Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.</li><li>
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.</li><li>
May prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.</li><li>
Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.</li><li>
Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.</li><li>
Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.</li><li>
Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.</li><li>
Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.</li><li>
Interact with study participants as directed/required by the protocol and/or study team.</li><li>
May be responsible for tissue sample collection per trial requirements.</li><li>
Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.</li><li>
Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.</li><li>
Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.</li></ul>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:<ul><li>
Excellent organization and communications skills required.</li><li>
Strong interpersonal skills &ndash; ability to effectively interact with all levels of staff and externals contacts.</li><li>
Must be detail oriented and have the ability to follow-through.</li><li>
Ability to effectively manage time and prioritize workload.
</li><li>Must practice discretion and adhere to hospital confidentiality guidelines at all times.</li><li>
Must have computer skills including the use of Microsoft Office.</li></ul>
MINIMUM JOB QUALIFICATIONS:
<ul><li>Bachelor&rsquo;s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required. 0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
</li></ul>SUPERVISORY RESPONSIBILITIES: None
PATIENT CONTACT:
All positions: May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<h3 class="jobSectionHeader">EEO Poster</h3>
.
Pay Transparency Statement
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$48,100.00 - $54,400.00</div>

Clinical Research Coordinator - Waldenstrom's Macroglobulinemia

Ovation Workplace services

<div>POSITION DESCRIPTION

Desktop Support Technician

Department: Information Technology | FLSA Classification: Non-Exempt | Employment Type: Full-Time
<div>
POSITION SUMMARY</div> 


The Desktop Support Technician delivers first- and second-level technical support across local and remote environments. Responsibilities include hardware and software troubleshooting, incident documentation in the IT ticketing system, and resolution of issues involving operating systems, enterprise applications, and peripheral equipment. This role requires proactive communication with end users and timely escalation to maintain SLAs and operational consistency across all shifts. 

<div>
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES</div> 


Primary duties are listed below. This list is illustrative, not exhaustive; additional duties may be assigned as business needs require. 

<ul><li> Deliver first- and second-level technical support to end users for hardware, software, and application issues via phone, remote access tools, and on-site assistance.</li></ul>
<ul><li> Log, track, and maintain accurate documentation for all reported incidents and service requests within the designated IT ticketing system.</li></ul>
<ul><li> Install, configure, upgrade, and troubleshoot supported Windows operating systems (currently Windows 10 and Windows 11) and the Microsoft Office 365 suite.</li></ul>
<ul><li> Provide foundational support for macOS environments to assist users of Apple devices.</li></ul>
<ul><li> Install, configure, and support enterprise applications, including Cisco Jabber and other organization-approved software.</li></ul>
<ul><li> Install, configure, and troubleshoot printers, desktop computers, laptops, and other authorized peripheral devices.</li></ul>
<ul><li> Perform routine preventive maintenance on computers, laptops, and printers to ensure continued operational reliability.</li></ul>
<ul><li> Conduct remedial repairs on desktops, laptops, printers, and related peripheral equipment.</li></ul>
<ul><li> Utilize diagnostic tools to troubleshoot issues related to network connectivity and workstation hardware and software.</li></ul>
<ul><li> Coordinate with third-party vendors to remediate complex audio/visual (AV) issues as required.</li></ul>
<ul><li> Provide timely and professional status updates to end users and stakeholders regarding open incidents and resolutions.</li></ul>
<ul><li> Support mobile device management (MDM) for iOS and Android devices within the enterprise environment.</li></ul>
<ul><li> Demonstrate working knowledge of networks, servers, audio/visual systems, smart devices, and telecommunications in support of a broad range of IT needs.</li></ul>
<ul><li> Perform other duties as assigned by management in support of departmental and organizational objectives.</li></ul> 

<div>
MINIMUM QUALIFICATIONS</div> 


Education
<ul><li> Associate's or Bachelor's degree in Computer Science, Information Technology, or a related field; OR an equivalent combination of education, training, and directly related work experience sufficient to demonstrate the required knowledge, skills, and abilities.</li></ul> 


Experience
<ul><li> Minimum of eighteen (18) months of hands-on experience in a desktop support, help desk, or IT support capacity.</li></ul>
<ul><li> Demonstrated experience supporting Windows-based environments, including Windows 10 and/or Windows 11.</li></ul> 


Certifications (Preferred)
<ul><li> CompTIA A+ certification or equivalent vendor-neutral credential.</li></ul>
<ul><li> Microsoft Certified Professional (MCP), Microsoft 365 Fundamentals, or higher-level Microsoft certification.</li></ul> 

<div>
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES</div> 

<ul><li> Proficiency in Windows operating systems, Microsoft Active Directory, Group Policy Objects (GPOs), and Microsoft Office 365.</li></ul>
<ul><li> Experience with PC and laptop hardware installation, configuration, and troubleshooting.</li></ul>
<ul><li> Familiarity with enterprise antivirus and endpoint protection solutions.</li></ul>
<ul><li> Experience with helpdesk ticketing systems and IT service management practices.</li></ul>
<ul><li> Knowledge of mobile device management (MDM) platforms supporting iOS and Android devices.</li></ul>
<ul><li> Familiarity with enterprise encryption solutions and Windows device management via Active Directory.</li></ul>
<ul><li> Strong analytical, problem-solving, and technical troubleshooting abilities.</li></ul>
<ul><li> Ability to effectively manage multiple priorities, work independently, and consistently meet established SLAs.</li></ul>
<ul><li> Excellent verbal and written communication skills with the ability to convey technical information clearly to non-technical audiences.</li></ul>
<ul><li> Demonstrated commitment to delivering high-quality customer service to internal stakeholders.</li></ul>
<ul><li> Ability to adapt to a rapidly evolving technology environment and shifting organizational priorities.</li></ul>
<ul><li> Willingness to work outside standard business hours, including evenings and weekends, for scheduled project support or emergency response as required.</li></ul> 

<div>
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT</div> 


The demands below are representative of those required to perform this role's essential functions. Reasonable accommodations will be made for qualified individuals with disabilities in accordance with the ADA and applicable state law. 

<ul><li> Regularly required to sit, stand, walk, and use hands to operate a computer keyboard and standard office equipment.</li></ul>
<ul><li> Occasionally required to lift and/or move IT equipment weighing up to 50 pounds.</li></ul>
<ul><li> May require bending, kneeling, or crouching to install or service equipment.</li></ul>
<ul><li> Work is performed primarily in a standard office or data center environment with moderate noise levels.</li></ul>
<ul><li> May be required to travel to or work at multiple organizational sites or client locations.</li></ul> 

<div>
EQUAL EMPLOYMENT OPPORTUNITY</div> 


We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy and related conditions), gender identity, sexual orientation, national origin, age, disability, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law, including Title VII, the ADEA, the ADA, GINA, and USERRA. 


Applicants requiring a reasonable accommodation to participate in the application or interview process should contact Human Resources in advance. 

<div>
DISCLAIMER</div> 


This description outlines the general nature and scope of the role and is not an exhaustive list of all duties or requirements. Management may modify responsibilities as business needs evolve.</div>

Desktop Support Technician

<div>Reporting to the Vice President of Inpatient and Ancillary Services, the Administrative Director (AD), Inpatient Hospital, will provide central administrative oversight for regulatory and governance of the Dana-Farber Inpatient Hospital in addition to leading strategic work as assigned for the service line. The AD of the Inpatient Hospital will be an integral part of the Inpatient Leadership team, partnering with clinical and administrative leaders across the organization to drive forward operational planning related to the Future Cancer Hospital. 
 
This position&rsquo;s work location is hybrid with two or three days per week remote. The selected candidate may only work remote days from a New England state (ME, VT, NH, MA, CT, RI).
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. 
Central Regulatory Oversight for DFCI Inpatient Hospital
<ul><li>Provides central leadership to ensure service line agreements for DFCI Inpatient Hospital are in place and governed. This includes creating infrastructure to ensure metrics are monitored centrally and partners with business owners to resolve issues.</li><li>
Ensures processes are in place for staff to be badged and trained in partnership with leaders and departments across the organization.</li><li>
Works across the organization to maintain up to date inpatient policies.</li><li>
Partners with the DFCI Quality and Patient Safety department and other departments as appropriate for follow through and oversight.</li></ul>
Strategic Planning and Implementation<ul><li>
Participates as part of the Inpatient Leadership team and drives strategic work forward as needed.</li><li>
Collaborates across a multitude of stakeholders to integrate ideas within broader planning.</li><li>
Identifies, develops and leads process improvement with clinical partners including physicians, nurses and physician assistants.</li></ul>
Financial Management
<ul><li>Prepares and monitor operating budgets and identify and address budget variances.</li><li>
Manages and provide oversight of expenses.</li><li>
Oversees contracts with external entities, grants, clinical trials and discretionary/gift accounts as needed.</li></ul>
Clinical Operations<ul><li>
Establishes, implements and monitors processes and procedures to ensure excellence.</li><li>
Monitors a variety of clinical metrics/reports to ensure efficiency and compliance with policies and programs.</li></ul>
Human Resource Management
<ul><li>Recruits and trains administrative staff providing career development opportunities.</li><li>
Completes annual performance reviews and provide on-going feedback for all administrative staff.</li><li>
Addresses performance issues with Human Resource assistance, when needed.</li><li>
Coordinates faculty offer/retention packages, provider training, and credentialing as needed.</li></ul>
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
<ul><li>Able to work independently and demonstrate ability to coordinate and balance complex projects and competing deadlines.</li><li>
Ability to accurately and concisely disseminate information in both written and verbal formats to diverse audiences.</li><li>
Excellent interpersonal and negotiation skills</li><li>
Strong analytical skills</li><li>
Proven ability to relate well to and work effectively with all levels of the organization including faculty, clinical staff, and front desk personnel</li><li>
A true commitment to and passion for excellent patient care and access.</li><li>
Ability to work within a team setting and foster collaboration</li></ul>
SUPERVISORY RESPONSIBILITIES:
The AD may direct others on a project management basis and over time supervise additional administrative or project management staff
MINIMUM JOB QUALIFICATIONS:
<ul><li>Bachelor&rsquo;s degree is required. Master&rsquo;s degree in business or health care administration (MBA, MPH, MHA) strongly preferred.</li><li>
7-10+ years of hospital administration experience required. Experience, in an academic setting, or strategy consulting preferred.</li></ul>
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
<h3 class="jobSectionHeader">EEO Poster</h3>
.
Pay Transparency Statement
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate&rsquo;s relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$109,400.00 - $128,600.00</div>

Administrative Director, Inpatient Hospital

Alliance for Clinical Trials in Oncology

<div>
 
 The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 
 
 In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 
 
 The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 
 
 Benefits of working at the Alliance for Clinical Trials in Oncology Foundation{{:}}
 
 <ul>
 <li>
 8 weeks of paid time off (including PTO, sick, and holidays) during year one
 </li>
 <li>
 Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
 </li>
 <li>
 Tuition reimbursement stipends
 </li>
 <li>
 Continuing Education
 </li>
 <li>
 3% employer match for retirement investments
 </li>
 <li>
 Annual Employee Performance Bonus Program
 </li>
 <li>
 Annual Cost of Living Adjustment
 </li>
 <li>
 50% commuter reimbursement
 </li>
 <li>
 Healthy Work/Life balance and flexibility
 
 </li>
 </ul>
 
 
 ROLE AND RESPONSIBILITIES
 
 
 
 &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 
 
 &bull; Send, track, and review study-specific and global feasibility questionnaires.
 
 
 &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 
 
 &bull; Track training information and issue trainings for sites and contacts.
 
 
 &bull; Collection of essential documents related to study start-up and review IP release packages.
 
 
 &bull; Prepare for and execute Investigator meetings and other site training programs.
 
 
 &bull; Assist with creation of start-up plans and templates.
 
 
 &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 
 
 &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 
 
 &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by{{:}} tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 
 
 &bull; Participate in co-monitoring activities.
 
 
 &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 
 
 &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 
 
 &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 
 
 &bull; Other related duties as assigned to meet departmental and company objectives.
 
 
 
 
 Requirements
 
 
 
 
 
 QUALIFICATIONS AND EDUCATION REQUIREMENTS
 
 
 
 &bull; A minimum of a BA/BS degree is required.
 
 
 &bull; Degree in a health or science major preferred.
 
 
 &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 
 
 &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 
 
 &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 
 
 &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 
 
 
 PREFERRED SKILLS
 
 
 
 &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 
 
 &bull; Strong interpersonal, written, and verbal communication skills.
 
 
 &bull; Flexible and adaptable to a small business workplace environment.
 
</div>

Clinical Research Associate

Massachusetts General Hospital

Cardiothoracic Transplant Pharmacist MGH

Clinical Pharmacist - Advanced Heart Failure and Cardiac Transplant MGH

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