Clinical Study Coordinator

Location: Fully Remote (US)

Contract Length: 8 Months

Pay Rate: $25-27.50/hr

Medical Research Support Associate

Job Description

Serves as a Therapeutic Area primary point of contact for externally sponsored and affiliate-run research operations in global Medical affairs.

Acts as the Subject Matter Expert for the review, approval, startup, maintenance, and closeout procedures related of Investor Initiated Studies (IIS) proposals and Affiliate sponsored studies (i.e.PMOS).

Responsible for the overall tracking and maintenance of the proposal workflow management system and CTMS Databases reporting of study information and metrics.

Identifies and escalates performance issues on studies to management and provide recommendations for resolution

Responsibilities:

• Responsible for executing all elements of externally sponsored research in compliance with quality standards (ICH/GCP, Global Regulations, and company policies and procedures) (e.g., drug supply management, ICBs, reviews and approves HCP invoices/ payments against executed contracts) with minimal oversight and guidance.
• Responsible for management of clinical essential documents and critical regulatory documents for assigned projects/studies to ensure document packets for study start-up are complete and accurate and consistent with the study start-up timeline.
• Routinely interact with Evidence Leads on assigned projects and in meetings.
• Supports the preparation of Scientific Review Meetings (Agenda/ Meeting Materials).
• Supports on audit/ inspection activities for GCP requirements.
• Responsible for regular updates appropriate for cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
• Participates in process improvement initiatives.

Qualifications/Experience:

• At least 4-6 years pharma related research experience
• Bachelor's degree
• Knowledge of externally sponsored research (IIS, external research collaborations)
• Knowledge of clinical study execution
• Knowledge of Good Clinical Practices and ICH/Guidelines, and/or other Global Regulations
• Excellent organizational skills, attention to detail, and strong oral and written communications skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.