Forest Research Institute (FRI)
—a wholly-owned subsidiary of Forest Laboratories, Inc.—drives the scientific research and development behind Forest’s top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute’s highly skilled professionals enable Forest to license compounds at virtually any stage—from preclinical development to products that are ready for FDA review—and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest’s more than 5,000 employees—including our 1,000 person strong Research Institute—contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
Regional Site Manager, Global Monitoring Operations
The Regional Site Manager (RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected. The RSM conducts all monitoring visits in accordance with Forest standards. In this duty, the RSM exercises responsibility across multiple projects and therapeutic areas. The RSM interfaces with clinical investigators, other site staff, and Forest personnel in order to carry out this responsibility. The RSM is completely accountable for site management and data quality for each assigned site.
The Regional Site Manager is a regionally based position.
Main areas of responsibility:
Conduct the following monitoring visits according to applicable Forest SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines as follows:
Pre-Study Site Visits (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) & Final Monitoring Visits (FMVs)
Partnering with sites to ensure recruitment goals are met, Assisting sites with operational needs (e.g. vendor activities, site payment), primary contact for all issues that arise with sites.
- Manage all site activities for assigned sites including:
Submit monitoring visit reports (MVRs) for all monitoring visits conducted, send follow-up letter to Principal Investigator summarizing visit conduct and all action items, contact the Regional Operations Manager (ROM) and Clinical Development representative (CDR) regarding significant site conduct issues, complete GXP Compliance audit responses in conjunction with ROM and GMO Program Lead.
- Communicate site status and monitoring activities, as follows:
Submission of MVRs in CORE, submission of paper copies of MVRs, freezing of all electronic case report forms, retrieval of all paper case report forms, completion of FOCAS calendar, submission of expense reports.
- Meet all departmental timelines and deliverables for the following activities:
Annual Global Monitoring Operations meeting and Regional Global Monitoring Operations meetings, as scheduled, Investigator Meetings for all assigned studies, Regional Site Manager teleconferences for all assigned studies.
- Attend and participate in all relevant meetings, as follows:
Minimum Qualifications to be considered for this position:
Education: Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree
Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization (5-7 years preferred). Experience working in more than one therapeutic area Familiar with Electronic Data Capture preferred
Forest Laboratories, Inc. - 10 months ago
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...