Clinical Research Manager

25-Sep-2024

Clinical Research Manager

Harvard John A. Paulson School of Engineering and Applied Sciences

66980BR

Job Summary

The Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) seeks a collaborative, impact-focused problem solver who wants to be part of a dynamic organization, dedicated to creating and commercializing novel approaches to societal challenges. As the Clinical Research Manager, you will oversee a team that supports in-person clinical and human subjects research studies. SEAS clinical research focuses on engineering: adaptive technology, wearables, motion, and motion capture. Our clinical research ranges from fully novel innovation to more established clinical trials, requiring creativity and compliance deftness. Our populations range from healthy to medical participants serving diverse community interests. 

If you are looking for the opportunity to innovate and apply your knowledge and expertise in a fast past-paced, entrepreneurial environment, while leading a dynamic, motivated team, this may be your next career move! The Clinical Research Manager will collaborate with staff, faculty, students, and SEAS science operations to navigate new and exciting research frontiers. To learn more about the cutting edge research happening at SEAS, please visit seas.harvard.edu.

Position Description

• Develop, manage, and streamline the SEAS-specific clinical research program. Engage with SEAS research teams and faculty to build off of the priorly developed infrastructure at the Wyss Institute (i.e., responsible for developing, modifying, and implementing standard operating procedures).
• Manage, train, and supervise a team of clinical research coordinators who support. SEAS and its collaborating institutions, industrial partners, and federal sponsoring agencies on physical clinical studies, primarily involving patient populations.
• Conduct internal monitoring of ongoing clinical research studies to ensure protocol and regulatory compliance with Good Clinical Practices and other applicable regulations. 
• Manage in-person clinical and human subjects studies including subject interaction and implementation of study design and controls. Ensure compliance with Institutional Review Boards at Harvard and collaborating institutions. Activities include, but are not limited to, screening, enrollment, medical clearance, scheduling, protocol modifications, participant transportation and remuneration at numerous test sites.
• For in-person clinical and human subjects studies, oversee corresponding data, database management, and data security in conjunction with SEAS Office of Computing (data security submission, data use agreements, etc.). 
• Initiate, prepare and submit documents to Institutional Review Boards (IRBs) and other governing/regulatory bodies, including, but not limited to, reliance agreements, research protocols, non-human subjects research applications, data use agreements, sponsor enrollment and data safety reports, clinicaltrials.gov submissions and maintenance.
• Work closely with and assist principal investigators in planning, execution and follow-up for all aspects of clinical and human subjects research. 
• Responsible for participant remuneration and transportation, including management of the Amazon and Uber Business accounts.
• Manage the clinical research email account and Crimson Fax portal.
• Liaise between faculty, principal investigators, federal sponsors (e.g., DARPA, NIH, NSF, DOD), University stakeholders (e.g., IRB, Computing, Vice Provost for Research, Research Compliance, Office of Technology Development, research monitors) and the sponsored research team to assist with grant and conflict of interest reporting requirements, 
• Facilitate relevant agreements (e.g., equipment loan agreements, CDAs, Risk and Release).
• Manage federally funded multi-site clinical trials. 
• Maintain appropriate research records and documentation (i.e., manage the regulatory and participant binders).
• Participate in writing clinical and human subjects research aspects of research proposals, reports, presentations, and publications.
• Demonstrate a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others.
• Manage, train, participate, and oversee researchers’ study coordination program, ensuring safety and compliance in the research lab’s performance of aspects of study participant recruitment, screening, enrollment, and follow-up. 
• During first year, manage the transition of IRB protocols from the Wyss Institute’s Clinical Research Team to the SEAS Clinical Research Team.

Additionally you may, as needed:

• Coordinate study participant recruitment, screening, enrollment and follow-up
• Assist with data entry into appropriate databases
• Coordinate the sharing of data with collaborators
• Periodically monitor study material and regulatory documents

This position will work closely with the Wyss clinical research team for an initial period of time.

Basic Qualifications

• Bachelor’s or advanced degree in physiology, public health, biology, engineering, or a related discipline. 
• Three or more years of related experience which must include clinical research administration or clinical research, or a combination of both.

Additional Qualifications and Skills

• Experience working with Institutional Review Boards for human clinical studies including protocol generation, continuing review, enrollment tracking, and completion of required forms (consent, adverse event, etc.)
• Prior experience managing people is preferred 
• Experience with participant recruitment and working with patients in a clinical setting, clinical research data entry, and multisite clinicalstudies.
• Experience with clinical studies involving medical devices, biologics, or drugs
• Excellent organizational skills, attention to detail, creativity, and effective communication (oral and written) 
• Ability to work on and track multiple projects and meet deadlines 
• Ability to handle confidential information with discretion  
• Willingness to work at all levels to accomplish team goals
• Proficient with office productivity software (MS Word, Excel, PowerPoint, etc.)

Certificates and Licenses

Certified Clinical Research Professional (CCRP) certification preferred 

Additional Information

• The Harvard John A. Paulson School of Engineering and Applied Sciences does not provide visa sponsorship for administrative and staff positions.
• Applicants should submit a resume and cover letter. 
• The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up-to-date on CDC-recommended vaccines.

Work Format Details

This is a hybrid position that is based in Massachusetts. Additional details will be discussed during the interview process. All remote work must be performed within one of the Harvard Registered Payroll States, which currently includes Massachusetts, Connecticut, Maine, New Hampshire, Rhode Island, Vermont, Georgia, Illinois, Maryland, New Jersey, New York, Virginia, Washington, and California (CA for exempt positions only). Certain visa types and funding sources may limit work location. Individuals must meet work location sponsorship requirements prior to employment.

About Us

The Harvard John A. Paulson School of Engineering and Applied Sciences serves as the connector and integrator of Harvard’s teaching and research efforts in engineering, applied sciences, and technology. Our core tenets are: educating broad-minded students; interdisciplinary research; integration across disciplines; and balancing theory, experimentation and practice to create an unmatched environment for learning and exploration. Through collaboration with researchers from all parts of Harvard, other universities, and industry, we bring discovery and innovation directly to bear on improving human life and society. For more information about us, please visit www.seas.harvard.edu.

Benefits

We invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards) to learn more about our outstanding benefits package, which may include:

• Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
• Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
• Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
• Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
• Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
• Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
• Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
• Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
• Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.

Job Function

General Administration

Department Office Location

USA - MA - Allston

Job Code

359057 Admin Dept/Program Admin

Work Format

Hybrid (partially on-site, partially remote)

Sub-Unit

------------

Salary Grade

057

Department

SEAS Science Operations

Union

00 - Non Union, Exempt or Temporary

Time Status

Full-time

Pre-Employment Screening

Criminal, Education, Identity

Commitment to Equity, Diversity, Inclusion, and Belonging

Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.

SEAS Commitment to Diversity
SEAS is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment. Some of our core values include respect for all, serving the greater good, and welcoming individuals from diverse backgrounds, experiences, and perspectives.

EEO Statement

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

LinkedIn Recruiter Tag (for internal use only)

#LI-CB1