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. This is Important Work
To ensure 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). May be responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications.
This is a full-time, direct hire opportunity for an experienced Senior Clinical Research Associate residing in the USA. Ideal candidates should have a variety of trial monitoring (field & remote) and full site management experience in areas such as Oncology, Infectious Diseases / Vaccines, Rare / Orphan Diseases, Immunology, General Medicine, etc. This position requires flexibility with travel, on average, 70-80% range. #LI-Remote Your Role
Required Education and Qualifications
- Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
- Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
- Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
- Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collect and review regulatory documents as required.
- Prepare site visit and telephone reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- Resolve site issues and determine status for IP shipment.
- Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
- May translate, coordinate translations or review completed translations of critical documents.
- Participate in feasibility and/or site identification activities.
- Assist the Project Team with the day-to-day management of clinical studies as required.
- Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
- Train, mentor and/or supervise junior staff.
- May be assigned as LCRA to a regional or global study.
- May be assigned as a reviewer of essential documents (GLP) as a 2 nd line or Independent Reviewer (IR).
- Conducts project co-monitoring, assessment visits and team training.
- Site contact for protocol clarifications and subject enrolment if CRA unavailable.
- Participate in the development of study newsletters communication as required.
- Assist with the development of project-specific training materials for team.
- Liaise with Business Development and make presentations to potential clients as required.
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
- Other responsibilities as required.
- At least four years clinical monitoring experience and/or relevant clinical trial experience.
- Relevant life science degree / medical / nursing background, or combination of education and experience.
- Skills to mentor and train other CRAs in a positive and effective manner.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Strong therapeutic background.
- Can demonstrate experience and knowledge in the CRO industry that will support POI's management of clinical trials.
- Has shown ability to successfully manage people/project issues.
- Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
- Demonstrates the ability to define and meet project requirements.
- Can demonstrate flexibility for improvement and creating solutions.
- Proven organizational abilities, and excellent written and oral communication and presentation skills.
- Excellent team player with team building skills.
- Strong customer focus.
- A thorough knowledge of regulatory submission and reporting requirements and guidelines.
- Excellent understanding of the drug development process.
Please apply online at www.pharm-olam.com/careers
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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