Clinical Research Coordinator

New Jersey /
Research - Quality & Risk Management /
Full-Time
Planned Parenthood of Northern, Central and Southern New Jersey, Inc. (PPNCSNJ) provides comprehensive reproductive and sexual health care, abortion services, education and information to women, men and teens at 17 health centers throughout 18 counties in New Jersey.

JOB SUMMARY:
 
The Clinical Research Coordinator supports the day-to-day implementation and coordination of clinical research studies and clinical trials throughout the Affiliate by working in collaboration with health center staff to set up and complete new studies; recruiting, screening and enrolling subjects, follow-up on project requirements while ensuring seamless implementation and research reporting.
 
ESSENTIAL FUNCTIONS:
Reasonable accommodations may be made for individuals with disabilities to perform the essential functions of this position.

The Clinical Research Coordinator performs a wide range of duties, including, but not limited to the following:
1.     Provide daily program support and coordination in the area of clinical research, while ensuring compliance with all applicable regulatory requirements, study protocols, contractual specifications and PPFA standards.
2.     Communicate with other staff members that are working within the scope of specific research objectives.
3.     Demonstrate knowledge of the affiliate-specific standards and templates for use by study teams.
4.     In collaboration with the Clinical Research Manager, participate in the recruitment and enrollment of study subjects.
5.     Communicate with Sponsor/CRO as directed by Clinical Research Manager; obtain required regulatory and study documents.
6.     Assist in the coordination of Investigator Meetings and Site Initiation Visits (SIV).
7.     Participate in the clinical operations review of new study protocols for feasibility, capability, logistics, personnel needs.
8.     Ensures patient visit reminders, visit confirmations and/or rescheduling of visits are done timely; while ensuring that the schedule of procedures are performed according to the study protocol.
9.     As directed by the Clinical Research Manager, may be delegated the task of a review for adverse events and any changes in patient history.
10.  Preforms timely collection of all data pertaining to patient visits and immediate completion of paperwork to be sent to Sponsor (via EDC or paper Case Report Form (CRF)).
11.  Confirm all required data points are collected and transferred to the CRF.
12.  Complete all CRFs before all monitoring visits during the study.
13.  Provide support during scheduled monitoring visits; answer monitor questions and facilitate visit logistics.
14.  Participates in the Affiliate’s efforts related to revenue cycle, which include but are not limited to: achieving goals for productivity; meeting or exceeding revenue targets; and expense management as budgeted.
15.  Demonstrates commitment to established Workplace Values: Trustworthy; Effective Communication; Respectful; Supportive; Collaborative; Excellence.  Practices behaviors that effectively demonstrate the Affiliate’s Workplace Values and supports goal to co-create a great workplace (see Workplace Values document received upon hire).
16.  Travels frequently throughout the Affiliate’s service area as required.
17.  Participate in the clinical operations review of new study protocols for feasibility, capability, logistics, personnel needs.
18.  Performs other duties as assigned in support of mission and as required to ensure delivery of consistent high quality research results including but not limited to incorporating new technology (EMR, patient portal or mobile devices).
 
KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS:
 
1.     Commitment and demonstration of excellent internal and external customer service and the ability to model skills to center staff.
2.     Knowledge of clinical research and efficient data collection and analysis.
3.     Knowledge of FDA/ICH regulations and Good Clinical Practices and Human Subjects Protections.
4.     Knowledge of project management.
5.     Ability to motivate and work with staff through active participation.
6.     Ability to be self-directed in essential duties.
7.     Attention to detail; ability to lead and follow processes and procedures from beginning to end.
8.     Recognized excellence in interpersonal and relationship-building, project management, and staff management skills.
9.     Ability to work collaboratively with staff throughout the agency to affect change.
10.  Strong organizational skills; ability to balance priorities, and contribute as a team player within the organization.
11.  Ability to access data to assist in the decision-making process.
12.  Demonstrated project management skills, including excellent follow through for multiple projects at multiple locations.
13.  Excellent written and verbal communication skills.  Able to communicate information in an organized and clear manner.
14.  Able to demonstrate behaviors that represent the Affiliate’s Workplace Values.
15.  Able to maintain and demonstrate strict confidentiality of all information.
16.  Intellectual curiosity, Demonstrated knowledge of quality assurance and risk management skills.
17.  Has computer skills and ability to learn/operate software programs.
18.  Maintains professional appearance and demonstrates professional behavior at all times.
19.  Ability to work flexible schedules and maintain punctual attendance.
20.  Able to work under pressure, remain calm, prioritize, and meet deadlines.
21.  Ability to relate to diverse communities.
22.  Ability to work as part of an interdependent team.
23.  Ability to remain open and non-judgmental towards colleagues and customers.
 
JOB REQUIREMENTS:
Minimum Education: Bachelor’s degree in a health related field. Clinical Research Certification (CRC/CCRC) is preferred.
 
Minimum Work Experience: 1 year minimum of coordinating research studies. 
 
Other Requirements: Valid driver’s license. Reliable transportation to travel throughout the service area.
 
LANGUAGE SKILLS  Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively 1:1 with co-workers, internal and external customers, and outside contractors and vendors. 
From your first day on the job, you’ll be immersed in a hands-on, hit-the-ground running experience. Every day will come with unique challenges – but rest assured you’ll never be alone in handling them – our team has each other’s backs. Beyond a meaningful career and an excellent benefits package, we offer career development opportunities and a supportive work culture. In addition to a competitive salary, PPNCSNJ offers medical, dental, vision, life insurance and a 401(k) plan.

PPNCSNJ is an Equal Opportunity Employer.