Clinical Research Project Manager

  • Charlestown, MA
  • Permanent
  • Full-time
  • 1 month ago
GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Clinical Research Program Manager’s main responsibilities include working independently under general direction of the PI to provide oversight of all lab research studies at a high level, as well as to provide an informal supervisory role for members of the clinical lab in the Brain Aging and Dementia Laboratory (BAnDLab). They would assist in the coordination of multi-center trials with NIH and other private industry funded trials and would review all IRB related material created by study staff prior to submission. They would assist in grant preparation and submission for NIH and industry deadlines under PI direction. They would be a unified point of contact for all sponsors to coordinate and monitor activity within the lab. They would also assist in proofreading if needed, prior to submission for publications and grants

The CRC Research Program Manager would be responsible for the supervision of all new clinical staff interviews and training, and well as maintenance of appropriate manual of operations for consistent guidance throughout staff transitions. They would be responsible for maintaining balance between coordinator workload throughout the lab, and report to PI with changes to be made. They will work with research staff to coordinate all laboratory activities including administrative tasks, study visits, room reservations, and data analysis and manuscript preparation plans to assure that the laboratory is meeting the general goals and commitments of the PI. They would complete regular check-ins with those they informally supervise, reviewing performance and goals in relation to the projects study staff is working on, and report any major issues to the PI.

The program manager would oversee ordering and maintenance of supply inventory and use of laboratory funds, reporting on each of these to the appropriate administrative staff. They would schedule all lab wide meetings, as well as help to coordinate smaller study meetings and record general minutes. They would be in charge of any extra-laboratory scheduling, including speakers, visiting research fellows, and student coordination.

The program manager would be responsible for assisting the recruitment manager with the maintenance of the lab’s participant recruitment tooling system when needed. They would be responsible for study quality assurance implementation, and a resource for determining a proper course of action during deviations or errors made during a study visit. They would report regularly to the PI with any larger issues that happen during the course of a study and be expected to manage the smaller issues independently.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Overall, the position will include the following primary tasks:
  • Resource for patients and staff for higher level issues
  • Supervises general operation and flow of the laboratory
  • Responsible for research staff orientation and relevant data collection training
  • Coordinates scheduling of study space with area collaborators
  • Management of laboratory meetings and coordination with visiting speakers
  • Conducts performance reviews with study staff related to data collection during research study visits
  • Monitors implementation of research protocols and working with study staff to achieve research goals
  • Oversees use of laboratory funds, monitoring invoices, making study purchases, and reporting to the PI on the status of financial matters
  • Ability to effectively supervise and train staff
  • Assist in the updating and completion of an operations manual, as well as general maintenance of Dropbox folders.
  • Strong database management and overall computer skills
  • Must possess strong budget management skills
  • Coordinates multi-center trials with NIH, FDA and private foundations as needed
  • Takes minutes at central meetings/conference calls and disburses information to investigators/sponsor
  • Contributes to grant writing, proposals, and presentations
  • Maintains centralized supply order list and monitors inventory.
  • Produces and maintains documentation for the IRB including overview of submission and amendments
  • Monitors laboratory safety, including space limitation requirements and proper use of PPE
SKILLS & COMPETENCIES REQUIRED:
  • Ability to make independent effective decisions
  • The ability to work with minimal supervision as well as part of an integrated research team
  • Excellent judgment and ability to interpret information and protocol requirements
  • Ability to effectively supervise others, and provide guidance and counseling to staff under their guidance
  • Excellent organizational skills to formulate and complete vigorous timetables and meet grant deadlines, and strong budget management skills
  • Proficiency in Microsoft Word, Excel and PowerPoint
  • Excellent interpersonal skills and communication skills
  • Attention to detail
  • The ability to prioritize multiple tasks and handle fluctuating priorities and deadlines.
Qualifications

EDUCATION:

Required: Bachelor's Degree

Preferred: Master's Degree

Field of Study/Additional Specialized Training: Certification in Project Management or similar training preferred. Psychology, neuroscience, or premedical science degrees preferred.

EXPERIENCE:

Required:
  • Minimum 5 years of research experience
  • Experience in clinical research interacting with patients
  • industry sponsors
  • Experience with IRB administration and data management.
  • Prior Supervisory experience
  • Experience with grant writing and management
  • Familiarity with sponsor and monitor interactions
Preferred:
  • Experience dealing with NIH grant proposals
  • Familiarity with imaging scanners
SUPERVISORY RESPONSIBILITY:

The individual will manage day-to-day activities of study staff to achieve research goals, including orientation, training, and research visit performance reviews.

Direct: 4-8

Indirect: 4-6

FISCAL RESPONSIBILITY:

The indiviual will be responsible for ordering research and office supplies for the lab, monitoring and reviewing scanning and other invoices, and reporting on usage of laboratory funds to the PI. He or she will also be responsible for monitoring all subject remuneration including parking, meal vouchers, and alternate transportation.

WORKING CONDITIONS:

This work will involve a mixture of remote and in office work.

Massachusetts General Hospital