- Trains, coaches, supports and mentors Site Clinical Research Managers and other team members.
- Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture.
- Provides on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs and relevant federal and state regulatory and institutional policies.
- Provides consultation during study start-up activities regarding development of study protocol, SOP or Case Report Forms (CRFs), site qualification, data collection and study conduct.
- Patricipates in site initiations and trainings.
- Assesses accuracy, completeness and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability.
- Performs study close-out monitoring activities.
- Provides pre-review assistance prior to regulatory inspections and submissions.
- Provides guidance on regulatory submissions to the FDA which may include an Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or other research under the purview of the FDA.
- Prepares and forwarding monitoring reports to program manager. Working with study staff to address any concerns.
- Promotes overall compliance and quality with research conduct through participation in education and training activities for professional staff.
- Assists in developing appropriate education and training sessions for investigators and clinicians involved in research.
- Works on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
- Regularly makes new recommendations on new processes, tools, and services that can impact multiple projects and other functions.
- May provide technical guidance and direction to support team members, contractors and/or other vendors.
- May serve as project/technical lead for ongoing processes or short-term projects within function or family.
- Performs related duties, as required.
-
Clinical Program Manager
1 week ago
Northwell Health Manhasset, United StatesPlans and implements clinical services, systems, and performance improvement activities as they relate to a multidisciplinary approach to providing care to patients. Collaborates with management in developing and maintaining policies and procedures for the department. · Job Respo ...
-
Community Outreach Program Manager
1 week ago
Northwell Health New Hyde Park, United StatesCoordinates communications, events, programs and initiatives within the Community Services department. · Job Responsibility · - Coordinates and organizes internal and external events including developing and implementing an itinerary; scheduling of staff and volunteers; securing ...
-
Manager of Residential Programs
3 weeks ago
Phoenix House of New York Springfield Gardens, United States**SUMMARY** · Manager of Residential Programs reports to the Director of Mental Health Services and is responsible for the management of the residential program. · **ESSENTIAL DUTIES AND RESPONSIBILITIES **include the following. Other duties and responsibilities may be assigned. ...
-
Apex Solutions Russell Gardens, United StatesLocation: 55430 Oberwesel | Contract Type: Full-time, temporary | Job ID: 805864 · Start of Training: | Planned End of Training: · At REWE, you can expect more than just a job, because we know: you are more than just an employee. In our REWE team, you can develop professionally ...
-
Program Manager
2 weeks ago
VNS Health Brooklyn, United States Full timeOverview · Manages and oversees the administration of a Behavioral Health Services (BHS) program, including the appropriate utilization and management of staff and the quality of program participants care with an emphasis upon an inter-disciplinary team approach to the delivery o ...
-
Clinical Research Program Manager
2 weeks ago
Northwell Health Westbury, United StatesLeads clinical research activities within the department under the direction of a physician; exhibits technical and functional expertise in the area of research through the development of protocols, hypotheses and educational curricula. Coordinates daily activities of a designate ...
-
Program Manager
2 weeks ago
Housing Works Brooklyn, United StatesHousing Works requires employees working in our Health Services division to be fully vaccinated against COVID-19, unless approved for a legal accommodation. If you need an accommodation for any reason, including related to this job requirement, please contact Human Resources. · H ...
-
Program Manager
3 weeks ago
Housing Works Brooklyn, United StatesHousing Works requires employees working in our Health Services division to be fully vaccinated against COVID-19, unless approved for a legal accommodation. If you need an accommodation for any reason, including related to this job requirement, please contact Human Resources. · H ...
-
Program Manager
1 week ago
Public Health Solutions New York, United States**Company Overview**: · **Program Description**: · Funded by the New York City Department of Health and Mental Hygiene (NYC DOHMH), the Harlem Health Advocacy Partners (HHAP) program aims to improve the health of NYC residents by supporting access to health and social services to ...
-
Program Manager
3 weeks ago
SEO Scholars New York, United States**Title**: Program Manager, Tech Developer · **Department**: SEO Tech Developer · **Reports To**: Associate Director, SEO Tech Developer · **FLSA**: Exempt · **Compensation**: $70,500 - $80,600 · Location/Hours · This is a full-time, hybrid position based out of our New York City ...
-
IT Program Manager
1 week ago
Voya Financial Newark, United StatesTogether we fight for everyone's opportunity for a better financial future._ · We will do this together — with customers, partners and colleagues. We will fight for others, not against: We will stand up for and champion everyone's access to opportunities. The status quo is not go ...
-
Program Manager
2 weeks ago
Cardiovascular Research Foundation New York, United States**SUMMARY** · Manages faculty and program content of conferences, symposia and workshops on behalf of CRF, and under direction of the Director, Program Development. · **ESSENTIAL DUTIES AND RESPONSIBILITIES** · - Works closely with the physician course director(s) to plan, organi ...
-
Program Manager
2 weeks ago
TYLin New York, United StatesTYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees throughout the Americas, Asia, and Europe, the firm provides suppor ...
-
Program Manager
2 weeks ago
Wall Street Bound, Inc New York, United States**YOU RESIDE IN NYC OR THE TRI STATE AREA**: · - **You have one or more years of financial services industry experience**: · - You are highly organized yet thrive in a fast-paced environment with competing priorities. · - You are dedicated to learning and can articulate confident ...
-
Program Manager
2 weeks ago
Amazon Services LLC New York, United States3+ years of program or project management experience · - 3+ years of defining and implementing process improvement initiatives using data and metrics experience · - Knowledge of Excel (Pivot Tables, VLookUps) at an advanced level and SQL · - Experience using data and metrics to d ...
-
Manager, Programming
3 weeks ago
Cineverse New York, United StatesNOTE: Cineverse is currently a 100% work-from-home company. While we may return to an office environment in the future, we do not have plans to return to an office setting at this time. When we return to an office environment, the incumbent may be required to work from the office ...
-
Program Manager
2 weeks ago
Amazon Services LLC New York, United StatesBachelor's degree or equivalent · - Experience with Excel · - 2+ years of program or project management experience · Amazon is looking for a bright, customer obsessed, and driven individual to join Amazon Fresh as a support partner for our Category team. This role will own tactic ...
-
Program Manager
1 week ago
Job Path New York, United StatesThe Manager of Job Development is responsible for Customized Job Development across all Employment programs at Job Path. The person in this role will take a lead in mentoring staff, developing strategies for researching and targeting employers, tracking job development efforts an ...
-
Program Manager
8 hours ago
Catholic Charities Community Services Bronx, United States**Description** · Beacon of Hope (BOH), a Division of Catholic Charities Community Services, seeks a Program Manager for its multi-licensed building on the grounds of Bronx State Psychiatric Center. The Program Manager works alongside a team of other Managers to provide oversight ...
-
Program Manager
3 weeks ago
Azimuth, LLC Hauppauge, United StatesJob Title: · - Program Manager · State/Area: · - New York · City · - Hauppauge · Primary Background · Secondary Background · Job Number: · - JN **Program Manager | Direct Hire Opportunity** · Are you looking for a challenging role in program management with great benefits? Join o ...
Senior Clinical Research Program Manager - Glen Oaks, United States - Northwell Health
Description
Job DescriptionProvides management of research administration at a clinical site(s) including monitoring the quality and accuracy of clinical trial data. Follows the established monitoring Standard Operating Procedures (SOP) and protocol- specific monitoring plan. Participates in site initiations and trainings.
Job Responsibility
Bachelor's Degree or equivalent combination of education/related experience, required.
3-5 years relevant experience, required.
Role is with Northwell Health/Vanguard - Contract Research Organization
FT on site at Zucker Hillside Hospital, Glen Oaks.
Experience with clinical trials, preferred.
*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.
When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
The salary range for this position is $66,220-$108,180/yearSalary ranges shown on third-party job sites may not accurately reflect ranges provided by Northwell Health.
Candidates should check Northwell Health Careers for accurate information and discuss salary/hourly details and our comprehensive benefits with a recruiter, if selected for an interview.