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Clinical Research Manager

Job Description

Clinical Research Manager

Full Job Description

Planned Parenthood of Southern New England

Care. No Matter What.
We are Planned Parenthood of Southern New England, one of the region’s largest and most trusted providers of reproductive health care. We are recognized for the wide array of services we provide, the outstanding sexual health education we deliver, and our strong commitment to social justice. Working for Planned Parenthood is more than a job; it’s being a part of a powerful movement. Together, we’ll take pride in shaping the future of sexual health and reproductive rights for all people.

Job Summary
The Clinical Research Manager (CRM) manages and participates in all activities of the Clinical Research department, both in the administrative offices and in the health centers. The CRM supervises the work of the Advanced Research Assistant (ARA) and works under the direction of the Director, Clinical Research to manage the Clinical Research Internship program, including managing the recruitment of new interns in collaboration with the Volunteer Services Specialist, and the ACA - Volunteer Coordinator in the health centers. The CRM manages the orientation activities for the interns, including updating all internship orientation documents and processes as needed. The CRM works with the Health Center Managers where interns are placed to assure that they are meeting the needs of the health center as well as the educational goals of the interns and collaborates with the DCR in intern evaluations and reporting to faculty.
The CRM assumes responsibility for project management of assigned study protocols which may include, but is not limited to initial feasibility data submissions, IRB submissions, creation of study-specific documents, financial accounting to the DCR, correspondence and meetings with monitors and presence at monitoring visits and addressing study queries and issues. As a senior member of the research team, the CRM acts as a liaison between the Clinical Research department and the health centers and works with the DCR to manage training and mentoring health center staff as well as serving as a study coordinator as needed, recruiting, and enrolling subjects, creating logs, shipping samples, and performing other duties as dictated by study protocol. The CRM collaborates with Health Center Managers to assure that all specific study activities are performed in accordance with Good Clinical Practices, Standard Operating Procedures, study protocols and compliance with all agency regulations including (but not limited to) universal precautions, OSHA regulations, sterile technique, hazardous waste disposal and HIPAA protections.

Essential Functions

    • Performs a range of activities to manage and support clinical research studies.
    • Manages interns and administrative staff under supervision in the design and preparation of study materials, including document packets, binders and lab kits, and supervision of interns, volunteers, and trainees in kit assembly.
    • Works with Volunteer and Intern Coordinator to involve volunteers, as appropriate, into the assembly of study materials.
    • Recruits and screens potential study subjects, including obtaining consent
    • Performs components of medical workup as needed, including obtaining blood and urine specimens from patients.
    • Processes and ships laboratory specimens per study protocols and all applicable regulations and advises, trains, and supervises health center staff in this function.
    • Follows procedures to protect and maintain the rights and confidentiality of all human study participants.
    • Providing care for subjects and data collection procedures in adherence with the assigned study protocol and in accordance with Good Clinical Practices and PPSNE Research Standard Operating Procedures.
    • Maintains financial tracking of subject compensation and preparation of invoices for study activities, and trains other clinical research administrative staff in financial tracking functions.
    • Maintains documentation required by study sponsors including source documentation, case report forms (print and electronic), study, regulatory, and patient binders, and maintains databases/spreadsheets to track study process and research data.
    • Manages preparation for, and conduct of, monitor visits conducted by study sponsors and CROs as assigned by the Director, Clinical Research. Works under direction of DCR to prepare and lead team in audits conducted by study sponsors, CROs, IRBs, FDA, PPFA and other entities.
    • Under guidance from the DCR, manages the review, revisions, and adoption of updated research SOPs.
    • Schedules regular team meetings with the administrative research team and DCR and provides agenda and minutes. Manages ongoing documentation of team meetings.
    • Works with study sponsor(s) as needed to facilitate daily operations and goals.
    • Works with Health Center management and staff to facilitate incorporation of clinical research into clinic operations and flow.
    • Assumes leadership and responsibility to serve as effective liaison between Clinical Research department and Health Centers.
    • Manages the training and mentoring of Health Center staff and interns in Clinical Research.
    • Manages IRB submissions and other regulatory documentation, development of clinical trial documents (e.g., protocols, consent forms), protocol feasibility assessments and reports
    • In collaboration with DCR, works on business development to procure new study contracts.
    • If appointed, serves as a member of the PPFA Planned Parenthood Research Network, attending all meetings and contributing to the growth of the nationwide network.
    • Travel to various Health Centers 60-80% of time may be required and expected.
    • Demonstrates flexibility and teamwork; understands the interaction between this position and others with whom the position works directly and indirectly.
    • Ensures that interactions incorporate PPSNE values of integrity, partnership, customer focus, communication, and quality.
    • Supports the agency’s mission and all the reproductive health services offered including family planning services, women’s health screenings, testing, and treatment of STI’s, birth control methods and abortion services.
    • Supports efforts of the agency’s diversity program to provide services that are culturally and linguistically competent; takes the initiative to develop own awareness and knowledge of diversity matters.
    • Self-awareness as it relates to racial and other identities: Is aware of multiple group identities and their dynamics, and brings a high level of self-awareness, empathy, and humility to interpersonal interactions.
    • Authentic relationship building: Interacts effectively and builds trust with a diversity of people and has demonstrated an ability to effectively work across difference. Communicates clearly and directly, continually able to hear, reflect, and act on feedback related identity and equity with the aim to learn
    • Interested in and Committed to Racial Equity: you are interested in expanding your analysis and knowledge about the role that racial inequity plays in our society, and are committed to building and/or deepening your commitment to racial equity in your work

Qualifications

    • Ability to maintain and design systems to facilitate workflow - demonstrated skills prioritizing and organizing workload
    • Superior attention to detail and accuracy.
    • Ability to follow processes and procedures from beginning to end within established timelines.
    • Superior verbal and written communication skills; good mathematical skills
    • Ability to handle discreet, confidential information
    • Proficiency with Windows based word processing, data management programs, graphics, and spreadsheets, especially Excel; ability to operate all office equipment
    • Ability to supervise and convey expectations of a team-centered cooperative work philosophy.
    • Desire to work as part of an interdisciplinary team to meet the needs of patients.
    • Ability to manage, lead, guide and mentor staff and interns, prioritize and handle multiple assignments simultaneously; and take initiative to address issues with minimal supervision.
    • Ability to work flexible hours (which may include evenings and Saturdays) and travel to PP sites
    • Clinic Assistant competencies must be maintained and kept current, including EHR.
    • Management of IT needs for the research department, including inventory and monitoring updates to laptops issued to research staff and interns.
    • Excellent customer service skills: ability to provide quality services to meet the individual needs of patients.
    • Strong supporter of PPSNE In This Together Values, mission and all of the reproductive health services offered.
Salary Range; Min $50,094 Mid $62,618 Max $78,273 and is based on full years of experience.
Due to our commitment to equity and fairness PPSNE does not negotiate salaries.

PPSNE is an equal employment opportunity employer and does not discriminate against any employee or applicant for employment on the basis of race, color, religion, sex, national origin, age, disability, veteran status, marital status, sexual orientation, gender identity, or any other characteristic protected by applicable law. We are committed to building an inclusive workplace that values diversity and inclusion and reflects the diversity of our communities and patients. We strongly encourage people of color and members of the LGBTQ community to apply.
PPSNE offers a comprehensive benefit package which includes; Health, dental and vision insurance, retirement savings, paid parental leave, tuition reimbursement, generous paid time off, a flexible spending account, wellness program and more.

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