Clinical Research Associate Manager

Site: reputed company Incorporated reputed company 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 reputed company that high-performing teams drive groundbreaking medical discoveries and invite reputed company applicants to join us and experience what it means to be part of reputed company. The Associate Manager works under direct supervision of a more reputed company 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 reputed company 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 reputed company processes to ensure compliance · Proctor meetings, supply meeting materials and reputed company 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 reputed company documents from reputed company relevant sources · Identify inaccurate reputed company documents and track reputed company 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 reputed company documentation is in reputed company prior to entering data. · Obtain and abstract reputed company 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 reputed company 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 reputed company 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. · reputed company 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 reputed company 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 reputed company a disease group · Potential to effectively supervise and train staff Job Summary

Summary

Oversees reputed company operational and financial activities reputed company to clinical trials for anterior and posterior reputed company 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 reputed company involved personnel to promote adherence to protocols. -Independently judges suitability of research subjects. -Responsible for quality control and may reputed company 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 reputed company study documentation.

Qualifications

Education Bachelor's Degree reputed company Field of Study required or Master's Degree reputed company Field of Study preferred Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Research reputed company 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 reputed company, we reputed company in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining reputed company pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The reputed company pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass reputed company elements contributing to your total compensation package. In addition to competitive reputed company 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 reputed company team will provide an overview of your potential compensation and benefits package. EEO Statement: reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religious creed, national reputed company, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that reputed company individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to reputed company 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 reputed company of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. reputed company Competency reputed company At reputed company, our competency reputed company defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The reputed company 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, reputed company hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Apply tot his job Apply To this Job