Clinical Research Associate Manager

Mass General Brigham•Boston, MA

1d•$63,253 - $102,596•Onsite

About The Position

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 CRC responsibilities and a working knowledge of all aspects of research management in a clinic setting. The Clinical Research Associate Manager maintains a working knowledge of all aspects of the Clinical Research Coordinator role and works in collaboration with CCPO Clinical Research Managers, Clinical Research Nurse Leadership to ensure a quality-based, patient-oriented flow within the research regulatory framework. The position is primarily on-site in a ambulatory practice setting.

Requirements

Bachelor's Degree Related Field of Study required
Research Related Experience 3-5 years required
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.

Nice To Haves

Master's Degree Related Field of Study preferred
Supervisory Experience 1-2 years preferred
Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group
Potential to effectively supervise and train staff

Responsibilities

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
Work with department leaders to resolve clinical issues.
Manage studies of a particular specialized program
Disease specific administrative tasks
Routinely assess clinic space and ensure all clinical research supplies are properly stored according to JAHCO requirements
Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance
Assist with pre-activation activities including completing complexity ratings, completing CRC activation checklists, develop flow charts, and ensuring all protocol requirements are clinically feasible.
Proctor meetings, supply meeting materials and develop group-specific tools
Implement and monitor procedures to ensure protocol compliance
Assist clinical team in screening potential patients for study participation
Schedule all protocol required tests and procedures
Coordinate patient appointments with physicians, nurses, and all test areas
Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers
Prepare pre-visit communication for providers to ensure required assessments are completed and documented
Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation
Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition
Coordinate, obtain, process, and ship protocol required tissue samples
Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)
Obtain vital signs and perform EKGs as required for individual studies
Administer quality of life assessments as required for individual studies
Scans in research documents and certifies these documents as copies