Clinical
Research Laboratory Roles
From
the pioneering public demonstration of the use of ether for anesthesia
to current breakthroughs in genetics and molecular biology,
MGH has always aggressively explored the diagnosis, cause, treatment,
and prevention of human disease.
There
are a continuum of clinical research opportunities within MGH
community. We work to explore preferred relationships
with pharmaceutical and biotech communities, link industry to physicians
for consulting, advisory board seats, and trials, provide outcomes
and disease management expertise, support the administration of
clinical trials and negotiate clinical trial agreements.
Clinical
Research at MGH offers varied therapeutic areas, large and well-characterized
patient populations, top investigators and thought leaders, highly
skilled study coordinators and state-of-the-art facilities.
Click here
to learn more about the current clinical trials and the Latest Discoveries
in Clinical Research at MGH.
Below
is a listing of the various roles available in clinical research.
Please carefully read the responsibilities and requirements for
each position. These descriptions will help you in finding the right
fit when searching our site for available positions:
Clinical
Research Assistant I
Files, enters data, Xeroxes, and performs minimal word processing.
Orders supplies, schedules study appointments, processes checks
and sets up meetings. Escorts patients to appointments. Ships and
stores specimens. Works under close supervision and regularly receives
reviews of work progress. Must exhibit careful attention to details,
good organizational skills, ability to follow directions, good communication
and word processing skills. High school diploma required, Associate's
degree preferred. No experience required.
Clinical
Research Assistant II
Above duties plus: collects and organizes patient data. Maintains
records and databases. Uses software programs to generate graphs
and reports. Assists with recruiting patients for clinical trials.
Obtains patient study data from medical records, physicians, etc.
Conducts library searches. Must be computer literate and knowledgeable
of clinical research protocols. BA/BS required. Previous relevant
course or project work required.
Clinical
Research Coordinator I
Above duties plus: verifies accuracy of study forms, updates study
forms per protocol, and maintains study codes. Prepares data for
analysis and data entry. Assists with formal audits of data, documents
patient visits and procedures and updates binders; assists with
QA/QC procedures. Assists with interviewing study subjects. Administers
and scores questionnaires. Provides basic explanation of study.
Performs study procedures such as phlebotomy, EKG, halter monitor,
etc. Assists with study regulator submissions, writes consent forms
and verifies subject inclusion/exclusion criteria. May assist with
the training and orienting of new staff. Must be able to work independently
and as a team member. Must demonstrate a respect and professionalism
for subjects' rights and individual needs. BA/BS required. Prior
healthcare and/or research experience preferred.
Clinical
Research Coordinator II
Above duties plus: maintains research data, patient files regulatory
binders and study databases. Performs data analysis and QA/QC data
checks and may develop systems for QA/QC, organizes and interprets
data. Independently judges suitability of research subjects, develops
and implements recruitment strategies, and acts as a study resource
for patients and families. Monitors and evaluates lab and procedure
data, administers, scores and evaluates study questionnaires. Acts
as a liaison between Research Affairs and Unit, files adverse events
with the IRB, and prepares for annual review. Recommends protocol
changes and may assist with writing protocols and manuscripts, works
with Principle Investigator (PI) to prepare complete study reports. May supervise staff in
lower level positions. Must demonstrate analytical skills and ability
to resolve technical problems, the ability to interpret acceptability
of data results and working knowledge of data management programs.
BA/BS required. A minimum of 1-2 years related experience required.
Senior
Clinical Research Coordinator
Above duties plus: responsible for quality control, reviews work
of trainees, develops study budgets and coordinates lab activities.
Plans, performs and designs statistical analyses. Designs research
protocols in conjunction with PI. Responsible for training, orienting
and assessing new staff. Provides direct supervision to staff in
lower level positions. Must demonstrate excellent communication
and interpersonal skills. Must be able to work independently and
display initiative to introduce innovations to research study. Must
have the ability to prepare and monitor budgets, to identify problems
and develop solutions, prioritize tasks and set deadlines. BA/BS
required, MA/MS/MPH preferred. A minimum of 3-5 years of directly
related experience required. Prior supervisory experience preferred.
Clinical
Research Program/Project Manager
Above duties plus: writes operations manuals, prepares CRS and edits
manuscripts. Supervises operations of all study staff, serves as
a resource for patients and staff, and monitors drug accountability
logs. Coordinates multi-center trials with NIH, FDA and private
foundations. Oversees all study-meeting plans. Reports study progress
at investigators' meetings. Takes minutes at central meetings/conference
calls and disburses information to investigators/sponsors, and attends
conferences. Responsible for management of all personnel. Must demonstrate
the ability to make independent and effective decisions. Must have
strong organizational and communication skills. A demonstrated ability
to supervise and train staff effectively is necessary. Strong database
management and overall computer skills, demonstrated analytical
skills to problem solve effectively and strong budget management
skills are all necessary. BS/BA required, MS/MA/MPH preferred. A
minimum of 5 years of research experience and prior supervisory
experience required.
Senior
Clinical Research Program/Project Manager
Above duties plus: Develops detailed protocol documents that meet
Federal/Institutional standards. Ensures study design's compatibility
with clinical practices. Provides critical input as to feasibility
of study design and available resources. Ensures document consistency
and conducts on and off-site training sessions to appropriate audiences.
Attends meetings and scientific conferences. May be responsible
for developing/managing the clinical trial's operating and capital
budgets. Coordinates and implements research design process at multiple
sites. Has direct and indirect supervision of the clinical trial's
staff. The ideal candidate must demonstrate the qualities listed
above as well as excellent judgment and ability to interpret information
and protocol requirements and an aptitude for technical problem
solving. Incumbent must also have a strong working knowledge of
NIH contract procedures and funding policies. MA/MS/MPH or PhD required.
A minimum of 7 years progressively more responsible experience in
a research-related field and supervisory experience with a financial
management background required.
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