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Clinical Research Associate Manager

Mass General BrighamBoston, MA
Onsite

About The Position

The Associate Manager works under the direct supervision of a more experienced manager. This role 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 and Clinical Research Nurse Leadership to ensure a quality-based, patient-oriented flow within the research regulatory framework. The position is primarily on-site in an ambulatory practice setting.

Requirements

  • Bachelor's Degree in a Related Field of Study required.
  • Research Related Experience: 3-5 years 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.
  • 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.
  • Standing Frequently (34-66%)
  • Walking Frequently (34-66%)
  • Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
  • Carrying Frequently (34-66%) 20lbs - 35lbs
  • Balancing Frequently (34-66%)
  • Reaching Frequently (34-66%)
  • Gross Manipulation (Handling) Frequently (34-66%)
  • Fine Manipulation (Fingering) Frequently (34-66%)
  • Feeling Constantly (67-100%)
  • Vision - Far Constantly (67-100%)
  • Vision - Near Constantly (67-100%)
  • Talking Constantly (67-100%)
  • Hearing Constantly (67-100%)

Nice To Haves

  • Master's Degree in a Related Field of Study preferred.
  • Supervisory Experience: 1-2 years preferred.
  • 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.

Benefits

  • Comprehensive benefits
  • career advancement opportunities
  • differentials
  • premiums
  • bonuses as applicable
  • recognition programs

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