Joulé
Drug Clinical Research Coordinator
Location:
Boston, MA
Schedule:
M-F (onsite daily) 8-5
Duration:
6‑month contract to hire
Pay Rate:
$25–30/hr
Start:
ASAP
Education
Bachelor’s Degree
Requirements
1–3 years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred
Knowledge of federal and institutional policies governing human clinical research
Proficiency with PCs and Windows‑based software, including Word, Excel and data management systems
Fluent in English and Spanish (preferred)
Strong organizational skills with the ability to multi‑task
Good judgment skills with the ability to interpret information and protocol requirements, and initiate appropriate actions
Accomplished documentation skills with meticulous attention to detail
Ability to complete tasks with aggressive deadlines and competing priorities
Comfortable with hospital in‑patient and out‑patient environments
Responsibilities
Assist Sr. Project Manager and team members with all phases of clinical research, including trial initiation, coordination/implementation/maintenance, and trial close‑out.
Assist in development of trial protocol IRB application and submission; prepare and/or review budgets; coordinate with ancillary departments/services to execute protocol elements; plan site initiation once IRB approval is received.
Working with a PA, conduct medical record screening of cardiovascular in‑patients and out‑patients to identify eligible potential trial subjects; approach potential subjects and/or their families with trial‑specific information; assist in recruiting qualified/interested participants.
Maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow‑up trial visits.
Obtain and process biological samples according to protocol (after completing any necessary training).
Assist with preparation and submission of final trial report to the IRB for review.
Assist in preparing all documents/files/binders/electronic data for sponsor‑initiated or FDA audits.
#J-18808-Ljbffr
Boston, MA
Schedule:
M-F (onsite daily) 8-5
Duration:
6‑month contract to hire
Pay Rate:
$25–30/hr
Start:
ASAP
Education
Bachelor’s Degree
Requirements
1–3 years of relevant experience in human clinical trial research, with cardiovascular disease experience preferred
Knowledge of federal and institutional policies governing human clinical research
Proficiency with PCs and Windows‑based software, including Word, Excel and data management systems
Fluent in English and Spanish (preferred)
Strong organizational skills with the ability to multi‑task
Good judgment skills with the ability to interpret information and protocol requirements, and initiate appropriate actions
Accomplished documentation skills with meticulous attention to detail
Ability to complete tasks with aggressive deadlines and competing priorities
Comfortable with hospital in‑patient and out‑patient environments
Responsibilities
Assist Sr. Project Manager and team members with all phases of clinical research, including trial initiation, coordination/implementation/maintenance, and trial close‑out.
Assist in development of trial protocol IRB application and submission; prepare and/or review budgets; coordinate with ancillary departments/services to execute protocol elements; plan site initiation once IRB approval is received.
Working with a PA, conduct medical record screening of cardiovascular in‑patients and out‑patients to identify eligible potential trial subjects; approach potential subjects and/or their families with trial‑specific information; assist in recruiting qualified/interested participants.
Maintain accurate case report forms, regulatory binders, and meticulous trial records; schedule and conduct follow‑up trial visits.
Obtain and process biological samples according to protocol (after completing any necessary training).
Assist with preparation and submission of final trial report to the IRB for review.
Assist in preparing all documents/files/binders/electronic data for sponsor‑initiated or FDA audits.
#J-18808-Ljbffr