Medasource
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Position: Clinical Trial Coordinator
Location: Hybrid (2 days on site)
Duration: 6 months with full-time possibility after
Job Description:
Our client is looking for a Clinical Trial Coordinator to be a part of the trial operations team, tasked with ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to sponsor/TIMI standards. Working independently and under general supervision, the Clinical Trial Coordinator will support one or more clinical trials and will be responsible for assigned administrative day-to-day project activities.
Minimum Qualifications:
- Bachelor’s degree and 1 to 2 years of research-related work experience
- Familiarity with EDC and CTMS systems preferred
- Detail oriented, strong organizational skills, customer service oriented, proficiency in MS Office products, strong written and verbal communication, ability to multi-task.
- Familiarity with drug development, clinical research processes and documentation, (study start up, maintenance phase, and study close out procedures) preferred but not required
Responsibilities:
- Identify and initiate communications with sites to obtain all relevant documents for project/trial.
- Manage 30+ clinical trial sites for the duration of the trial – start up to close out.
- Collect and review the site’s essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval.
- Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
- Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
- Identify issues/trends that require escalation to management and provide input to resolution as appropriate.
- Update and maintain internal databases, tracking systems, project plans, and study files.
- Prepare presentation materials for internal and external meetings. Draft meeting agendas and minutes.
- Work with Project Manager to support trial processes and distribution of information and reports to monitors in both North America and internationally.
- Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial. Comply with applicable SOPs.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
JO-2310-140034