Clinical Research Assistant 2
Company: Connecticut Children's Medical Center
Location: Hartford
Posted on: June 21, 2022
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Job Description:
SUMMARY Directly reporting to the Lead Clinical Research
Associate for designated area(s) of the Clinical Trials Department,
under limited supervision, independently performs clinical research
activities for a broad range of assigned non-therapeutic research
studies in accordance with federal and state regulations,
Institutional Review Board approvals and Connecticut Children's
policies and procedures. Additionally, supports Clinical Research
Associates and Clinical Research Nurse Coordinators in the
coordination and management of clinical trials. With increasing
on-the-job experience, successful completion of competencies and
mentorship, will assume responsibility for study coordination of
clinical trials in addition to non-therapeutic studies. Works
collaboratively with investigators, clinical research nurses,
ancillary team members, and external parties (e.g. study Sponsors)
to successfully execute trial specific protocol requirements. ROLE
RESPONSIBILITIES STUDY COORDINATION AND MANAGEMENT (performs
responsibilities under limited supervision): *Ensures compliance
with study protocols and clearly and thoroughly documents each
study participant visit.*Participates in recruitment and selection
of clinical trial participants by reviewing medical history as well
as protocol specified inclusion and exclusion
criteria.*Participates in the consent/assent process ensuring the
study participant and/or legal guardian understand all aspects of
the study protocol including risks and benefits of participating in
the clinical trial.*Provides timely information regarding each
study visit to all ancillary departments as required e.g., Office
for Grants and Sponsored Programs, pharmacy, institutional review
board, etc.).*Completes data collection as specified by the study
protocol.*Provides timely information to study Sponsors including
completion of data queries.*Oversees the procurement, preparation
and shipping of research specimens as needed.*Meets with the
Principal Investigator regularly during the trial to review
progress, identify challenges and reconcile issues as necessary;
documents meetings with investigators.* May transport study
medication as needed from Connecticut Children's research pharmacy
to a Connecticut Children's outpatient clinic in accordance with
Connecticut Children's Medication Transportation Policy.STUDY
START-UP/CLINICAL TRIAL INITIATION (performs responsibilities under
limited supervision):* Participates in Connecticut Children's
internal study start-up process and works collaboratively with the
study team to prepare study for activation.* May assist in the
development of protocols, consents, and/or data collection
methods.* Completes IRB submissions and organizes all regulatory
and subject research records.*Establishes clear and consistent
communication with the study Sponsor and all Connecticut Children's
team members involved in the study.*Attends clinical trial
investigator meetings coordinated by the trial Sponsor.RESEARCH
COMPLIANCE (performs responsibilities under limited
supervision):*Assists team members in performing quality assurance
checks in accordance with department SOPs to ensure protocol
compliance, Good Clinical Practice (GCP) and all other applicable
regulatory requirements. *Ensures all research records are
compliant with study protocol requirements prior to monitor
visits.TRAINING AND EDUCATION:*Participates in all internal and
external training sessions and meetings for assigned
studies.*Participates in internal Clinical Trials team meetings and
Connecticut Children's research education sessions.*Maintains
professional expertise through involvement in professional
organizations and continuing education programs.*Demonstrates
knowledge of the age-related differences and needs of patients in
appropriate, specific populations from birth through young adults
and applies them to practice. *Demonstrates cultural sensitivity in
all interactions with trial participants and families. *Values
cultural diversity and other individual differences in the
workforce.* Demonstrates support for the mission, values, and goals
of the organization through behaviors that are consistent with
Connecticut Children's Medical Center standards.*Performs other
related responsibilities as assigned.MENTORING & EDUCATIONAL
RESPONSIBILITIES:*Provides education regarding study specific
protocol requirements to ancillary Connecticut Children's team
members involved in the execution and conduct of the trial.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED KNOWLEDGE OF (acquired
within the first 3 months of employment):Research protocols,
research regulations, human research protection principles and Good
Clinical Practice (GCP) guidelines.SKILLS (acquired within the
first 3 months of employment):* Demonstrates an understanding of
protocol elements, the ability to execute study procedures, and the
ability to anticipate and mitigate potential protocol
non-compliance.* Demonstrates an understanding of the elements of
clinical trial participant safety, related documentation and
reporting. Recognizes situations requiring prompt escalation and
demonstrates actions to minimize risks.* Demonstrates and
understanding of investigational product development process and
applies key regulatory requirements to control these processes.*
Demonstrates an understanding of procedures to prevent potential
ethical and professional conflicts and how to manage such events
should they occur.SKILLS (current knowledge required):*
Demonstrated proficiency in Windows environment; intermediate to
advanced level word processing and spreadsheet skills (Microsoft
Word & Excel); and intermediate to advanced skills developing
presentations (Microsoft Powerpoint); advanced skills in database
design and database management (Microsoft Access)* Excellent oral
and written communication skills.* Highly organized and adept at
project management.ABILITY TO (acquired within the first 3 months
of employement):* Ability to collect, verify and report study data
via source documentation and apply ALCOA-C practices to the
collection of data in a given study.* Ability to coordinate and
manage communications with multiple internal and external
stakeholders including clinical trial participant and family,
ancillary team members, and study Sponsors.*Ability to problem
solve, organize and adapt to changing priorities. Work Environment:
Both clinical and non-clinical work environment. Physical
Requirements: Amount of Time (Choose which ones do apply)
Occasional 25-50% day Frequent 50-75% day Constant > 75% day
Stand --' --- --- --- Walk --- --' --- --- Sit --- --- --' ---
Manual Dexterity/Repetitive use of hands, wrists, arms, elbows ---
--- --' --- Forward reach w/hands and/or arms --' --- --- --- Climb
or balance --' --- --- --- Stoop, kneel, crouch --' --- --- ---
Overhead/above shoulder reaching --' --- --- --- Choose Applicable
Lifting Demands LIFT Floor-Waist Waist-Shoulder Above Shoulder
Frequently Frequently Occasionally 15 - 25 lbs. Occasionally
Occasionally Occasionally 25 - 40 lbs. Occasionally Occasionally
Not Applicable 50 lbs. Occasionally Occasionally Not Applicable
PUSH/PULL Not Applicable 50 - 100 lbs. (push/pull only) Not
Applicable More than 100 lbs.* (push/pull on wheels only) *indicate
weight range Not Applicable lbs * Bachelor's degree in a health
care related field. Degrees in other areas may be substituted on a
case-by-case basis.* Previous clinical research experience
preferred (e.g. internship or professional role.Equal Opportunity
Employer Minorities/Women/Protected Veterans/Disabled
Keywords: Connecticut Children's Medical Center, Hartford , Clinical Research Assistant 2, Healthcare , Hartford, Connecticut
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