Clinical Research Associate I at Pharm-Olam, LLC

About Pharm-Olam, LLC: 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. #LI-Remote

Summary: 

Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).

Responsibilities

• Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Pharm-Olam SOPs for monitoring requirements.

• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. 

• Collects and reviews regulatory documents as required. 

• Prepares site visit reports and telephone contact reports. 

• May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, and developing study documents. 

• Resolves site issues, including site recruitment challenges and determines status for IP shipment. 

• Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts. 

• Informs team members of completion of regulatory and contractual documents for individual sites. 

• Attends Investigator Meetings (IM) and study specific training meetings. 

• May translate, coordinate translations or review completed translations of critical documents. 

• May participate in feasibility and/or site identification activities.       Contact local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed. 

• Performs internal in-house monitoring tasks. 

• Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.  

• Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.

Working Relationship: 

• Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager.

• Collaborates with Pharm-Olam project team members.

• Collaborates with Pharm-Olam and local support personnel.

• Liaises with Investigators, Site Staff, Regulatory Authorities and Ethics Committees.

• Liaises with Sponsor scientific and medical personnel.

• Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organisations.

• Liaises with Quality Assurance personnel.

Qualifications

• Relevant life science medical / nursing degree or relevant degree or background preferred.

• Customer service orientation.

• Sound knowledge of medical terminology and clinical monitoring process.

• Attention to detail.

• Ability to travel for 3 to 5 days on site per month, depending on the project needs.

• Excellent communication in English in both written and verbal skills.

• Computer literate and proficient in Microsoft Office.

• Excellent interpersonal and organizational skills.

• Ability to work independently and to effectively prioritize tasks.

• Ability to manage multiple projects/tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients.