The 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.
Our Jersey City, NJ office has an exciting opportunity available in Clinical Pharmacology & Drug Dynamics for a Principal or Sr. Clinical Scientist.
Duties and Responsibilities
The Principal /Sr. Clinical Scientist will be responsible for studies under the direction of the Director or designee, which will include but is not limited to:
Preparing protocols and assisting with case report form development, site selection, managing investigational drug and clinical study supplies, planning monitoring trips, and ensuring that the clinical trial is conducted in compliance to GCP/ICH guidelines, FDA regulations, and Forest's standard operating procedures relevant to the authoring of clinical study reports, analyzing PK/TK data, and supporting IND and NDA activities.
Additional Responsibilities to include:
20 to 30% travel for study monitoring
Plan, manage, and coordinate multiple Phase I clinical trials under the direction of the Director or designee.
Manage the successful and timely execution of clinical trial activities through regular phone and email contact with sites and vendors, and use of tracking tools; prepare clinical trial protocols and amendments.
Assist in developing case report forms in collaboration with clinical team, ensuring consistency with protocol
Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system; generate and resolve clinical queries in EDC. Participate in SAE reconciliation with Data Management, Medical Coding, and Global Drug Safety.
Work with Biostatistics and Data Management to ensure data collection meets standard requirements and can be analyzed
Participate with site feasibility and the identification and selection of qualified investigators, study sites, and CROs; support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Review site informed consent forms and provide support to the submission of site's local IRB
Conduct site start up, interim maintenance and close out activities
Create and review monitoring plans
Document and track protocol deviations and violations
Oversee the shipment of drug supply, packaging, and labeling. Work with PR&D to ensure no delays occur.
Initiate and support site, vendor, and CRO selection activities; receive and review bid proposals and contribute to vendor specifications development
Manage the activities of the study site, vendor and CROs, Manage CROs for outsourced studies.
Manage CRO regulatory documents, review work performed, and monitor CRO performance
Conduct site start up, interim maintenance, and close out activities
Coordinate transmission of all study data
Review statistical analysis plans and data tables and listings
Support IND and NDA activities (e.g. provide study report summaries, tabular listing of study reports, input for annual reports and Investigator Brochures)
Education: Bachelor's degree required, concentration in life sciences or related required.
Experience (experience will vary based on level):
At minimum 4 years of clinical research experience, including at minimum 2 years of Phase I experience
Must be familiar with the process and review of budgets
At minimum 3 years of monitoring experience preferred (conducting pre-site study visits, site initiation visits, interim visits and close out visits).
Experience in reviewing data table and listings
Protocol development experience
Familiar with study regulatory requirements and maintenance.
Experience in data clarification and/or query resolution
Basic medical and scientific knowledge in various therapeutic areas
CRA Training from a national clinical research association (eg, ACRP, Barnett International, PERI) a plus.
Knowledge, Skills and Abilities:
Knowledge of the drug development process
Knowledge of GCP/ICH guidelines and FDA regulations
Knowledge of EDC system
Good organizational and interpersonal skills
Ability to work independently
Ability to communicate effectively verbally and in writing. Good presentation skills
Experience using organizational and tracking tools in Excel
Computer and software skills (Word, Excel, Powerpoint)
Data analysis using WinNonlin (preferred)
Forest offers generous compensation packages; comprehensive training programs; stock options, profit sharing and 401(k) company match; excellent benefits packages; and a supportive work environment that thrives on teamwork and a commitment to excellence.
Committed to continuing diversity at work.
Please apply directly to our company website through the following link:
Note to 3rd party agencies and search firms:
Thank you for your support and interest in Forest Laboratories Inc. It is our practice to recruit and fill career opportunities through the Human Resources, Talent Acquisition organization. We ask that you not submit candidates for consideration to us without receiving a formal written request from the Talent Acquisition organization to do so. All resumes submitted; (with or without use of your agency access credentials) will be deemed unsolicited and as such will not be eligible for placement fees. We look forward to working with you and appreciate your cooperation.
Forest Laboratories, Inc. - 24 months ago
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