Study Support Coordinator I Jobs

Minimum 6 years or successful execution of over 30 clinical trial studies or collaborative biomedical laboratory study experience (Study Coordinator II)

Preferred experience in managing investigator-initiated, industry-sponsored, or military studies.

Ability to analyze data and summarize findings for incorporation into reports.

The Contractor shall match sponsored studies with appropriate Principal Investigator.

The Contractor shall assure that logs and collected data from patients enrolled in the study remain confidential.

Must have a Bachelors of Science in biomedical science field or nursing

Bachelor’s Degree in business administration, finance, science or related field or equivalent experience.

Central Services Specialist - ICF Management

Co-manages maintenance of the centralized Informed Consent Form mailbox.

Minimum of three years of relevant experience in the biopharmaceutical/CRO industry.

Experience in negotiating vendor contracts/budgets.

Proven ability to effectively manage change.

Relevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skills,

Administrative tasks and activities may be requested by a line manager, study team member, or GSO department staff.

Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archival

Activities and responsibilities may include:

The SS I is not allocated as a resource to any specific study or program.

BOARD Quarterly MVR GSO Compliance and other metrics

currently conducting several trials and are seeking an experienced Assistant Study Coordinator.

Attending site qualification and initiation visits

280 Washington St, Suite 204

MetroBoston Clinical Partners is a growing research organization with two offices in the

metro Boston area. We have a friendly staff and a great work environment. We are

Assistant Study Coordinator part time

Oversee data collection, management, and entry into study databases, ensuring accuracy and completeness

Strong knowledge of clinical research processes, regulations, and guidelines.

Excellent organizational, communication, and interpersonal skills.

Collaborate with study teams to develop and implement study protocols, ensuring compliance with regulatory guidelines and ethical considerations

Coordinate participant recruitment and enrollment activities, including screening, selection, and informed consent processes

BA/BS degree in a relevant subject

Assist with data collection, electronic data entry and audit checks.

Ability to multi-task and manage time effectively

Ability to pivot to meet changing requirements as needed

Experience drafting regulatory submissions for IRB

Experience with protocol development and consent writing

Experience working at a clinical research site and/or conducting federal clinical research

Experience with adverse event reporting per clinical standards and FDA requirements strongly preferred

Work with Data Managers and Data Team members for forms preparation, and completion of adjudication procedures

Experience working in an academic or NIH research environment preferred

Knowledge of medical terminology preferred

Bachelor's degree req'd with 2 years experience in public health, clinical research or related field.

Implement study activities in accordance with NIH and FDA regulations

Support the organization with daily tasks including user management, site management, equipment requests, data entry and report generation

Provide support for front-end client activities across multiple clinical research studies

Work closely with clients to ensure all data required for study start-up is collected and maintained

Provide details and information to clients in response to inquiries regarding study support and set-up

Update project-related internal databases and electronic files to ensure accuracy

Assist with special department projects