Clinical Research Associate Manager

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management. Management responsibilities will include the following: · Provide first-line supervision to a minimum of 4-8 FTEs that may be across multiple different specialties of varying complexity and/or have management duties of equivalent responsibility. · Facilitate new hire, correction action, and performance evaluation process for research staff · Train new staff and assess continuing education needs · Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation · Manage staff productivity and quality of work produced by assessing work effort on individual studies · Builds strong, positive working relationships with clinical research associate (CRA) managers and maintain them over time Management responsibilities may include the following · Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance · Proctor meetings, supply meeting materials and develop group-specific tools · Participate in pre-activation activities including attending SIVs and assisting with CRDSP activation readiness. · Assist Clinical Research Manager to identify new program-wide data entry training needs Data management responsibilities may consist of the following: · Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker · Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements · Proactively take steps to obtain missing source documents from all relevant sources · Identify inaccurate source documents and track source document inconsistencies until resolved. · Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems. · Ensure appropriate documentation of own study-specific delegation and training prior to entering data. · Ensure adequate source documentation is in place prior to entering data. · Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. · Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations · Independently manage tumor response data entry · Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies · Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies · Enter all required correlative research blood samples and clinical safety laboratory specimen results into study-specific electronic data-capture system independently as required for individual studies · Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies · Work professionally with sponsor representatives to review and correct data recorded in the case report forms. · Track and appropriately manage sponsor data entry deadlines · Resolve and answer data queries with minimal errors. · Perform standard data management quality control steps. · Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly. · Remain flexible and adapt to change and variety on the job. · Effectively handle unexpected situations and changing research subject and protocol conditions Skills/Abilities/Competencies Required · Demonstrated time management and organization skills · Strong written and verbal communication skills · Knowledge of current and developing clinical research trends · Sound interpersonal skills · Ability to work independently and display initiative · Demonstrated ability to successfully manage multiple projects · Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group · Potential to effectively supervise and train staff Job Summary Summary Oversees all operational and financial activities related to clinical trials for anterior and posterior segment research services. Supervises the daily organization and functioning of assigned projects to subordinates. Serves as a resource to Program Administrators, Principal Investigators, and Grants Administration personnel. Does this position require Patient Care? No Essential Functions -Supervises and trains subordinates and all involved personnel to promote adherence to protocols. -Independently judges suitability of research subjects. -Responsible for quality control and may develop systems for QA/QC. -Designs research protocols in conjunction with PI; recommends protocol changes and contributes to writing protocols and manuscripts. -Files adverse events with IRB and acts as liaison with Research Affairs. -Responsibly for safety, confidentiality and adherence/compliance to federal guidelines (HIPAA, OHRP etc.) of all study documentation. Qualifications Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred Knowledge, Skills and Abilities - Trains, manages and mentors subordinate staff. - Assigns responsibility to subordinates. - Ability to design, prepare, deliver and evaluate clinical research programs. - Exceptional project management skills. - Effectively arranging resources and managing multiple small to large projects in a cross-functional environment. - Effective multitasking and time management skills. - Strong analytical, quantitative and communications skills. 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 Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $63,252.80 - $102,596.00/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. 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 tot his job