Clinical Trial Associate H15

Clinical Trial Associate H15

11 nov
Pharm-Olam, LLC

11 nov

Pharm-Olam, LLC




Acts as the primary administrative support to Pharm-Olam clinical study teams, as required by Project Managers and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member.

This is a full-time direct hire opportunity for a Clinical Research Professional (permanent or contractor) who has a strong background supporting various clinical trial studies. This position is open to remote based Professionals in Mexico.

Your Role

- Assists CRAs, Lead CRAs (LCRA), Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administration of clinical studies.

- Tracks critical documents and informs PM / CTL and/or LCRA of outstanding documents.

- Accurately updates and maintains clinical systems within project timelines.

- Prepares, distributes, files, and archives clinical documentation.

- Reviews study files periodically for accuracy and completeness.

- Prepares and distributes clinical trial supplies and maintains tracking information.

- Assists PM / CTL / LCRA / CRAs with collection and filing of critical documents.

- Attends local Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.

- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

- Performs administrative tasks to support team members with clinical trial execution, as required.

- Prepares Trial Master File according to Pharm-Olam SOPs with the guidance of Project Manager and/or experienced CTAs, as required.

- Assists with the preparation of Investigator Site Files, Investigator Manuals and Training Manuals with the guidance of Project Manager, experienced CTAs, as required.

- Assists with returning/archiving study files.

- As needed, communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals.

- May participate in feasibility and/or site identification activities.

- May attend clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.

Working Relationship:

- Reports to Clinical Trial Associate Manager, COM or designee.

- Collaborates with project teams and all Pharm-Olam staff.


- Fluency in English (spoken and written)

- Customer service orientation

- Strong verbal and written communication skills

- Computer literacy, proficiency in Microsoft Office

- Excellent interpersonal and organizational skills

- Ability to work independently and to effectively prioritize tasks

- Ability to manage multiple projects

- Attention to detail

- Ability to establish and maintain effective working relationships with co-workers and managers.

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