Compliance coordinator job description

+ Department: VP for Research

+ School Area: VP Research

+ Employment Type: Full-Time

+ Employment Category: Exempt

+ Visa Sponsorship Available: No

+ Schedule:

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Information on MIT's COVID-19 vaccination requirement can be found at the bottom of this posting.

COMPLIANCE COORDINATOR, Office of the Vice President for Research, to prioritize proposals and disclosures--based on level of risk--for attention by COI or export control officer; gather information; and analyze scientific research project statements of work--for review by respective officer--to determine risk with federal (PHS, NSF, DoD, DOE) and MIT policies. Will monitor and follow up with responsible parties to ensure that members of the MIT community are current on training related to conducting human and animal research; develop, curate, and manage a document management system for maintaining electronic/hard-copy files of all reviews and management plans; maintain database and status of current export control activities; draft preliminary COI management and export control plans for review by respective officers; maintain COI and export control website content, ensuring it's up-to-date and informative; assist with maintaining outreach to the MIT community through ongoing foreign influence, COI, and export control training/information sessions and development of new teaching materials; field and screen planned international shipments; perform administrative tasks as needed; and assist chief research compliance officer with scheduling.

Job Requirements

REQUIRED: bachelor's degree in related field; two years' relevant experience; self-motivation; excellent organizational and written and verbal communication skills; discretion with complex, highly sensitive information/material; understanding of the social, ethical, and legal contexts in which research activities are conducted in academia and industry; attention to detail; and proficiency with MS Office. Must be able to work with limited supervision; manage multiple concurrent tasks in a fast-paced environment; learn, interpret, and communicate MIT and federal policies/guidelines, and implement non-paper-based tools to help faculty and staff with COI and export control processes. PREFERRED: familiarity with QuickBase or similar database tools. ob #19440-7revised 10/6/22

Care. No matter what:
PPLM has been a leader in promoting sexual health for more than 90 years. We believe that all people deserve the information and expert services to make informed, personal decisions that affect their health, their lives and their futures. We are the state's leading provider of sexual and reproductive health services. We educate families and empower youth to make responsible choices that lead to healthier lives. We advocate for policies that improve sexual health.

Our Commitment to Diversity, Equity and Inclusion:
PPLM believes sexual health is essential to every person's overall health, well-being and happiness. We recognize that geographical and systemic barriers entrenched in discrimination and stigma prevent people in Massachusetts from having equitable opportunity to choose their own path and access to sexual and reproductive health care. In order to address health equity in communities across Massachusetts in an authentic way, we must start with ourselves. We are taking focused steps to make progress in our own organization. We have embarked on a diversity, equity and inclusion journey that will lead us toward becoming an organization that better reflects our patients and embodies cultural humility. We are wholeheartedly committed to this work.

POSITION SUMMARY:
The Compliance Coordinator reports to the Director of Compliance and assists with the implementation of Planned Parenthood League Massachusetts's (PPLM) Compliance Program. The Compliance Coordinator must be adept at working with numerous departments and levels of personnel on projects and initiatives within a cross functional environment. The Compliance Coordinator will be highly involved in assuring that all departments conform to the Planned Parenthood Federation of America's standards, PPLM's protocols, and are in compliance with regulatory requirements.

Requires advanced administrative skills. Requires a high degree of organization, the ability to prioritize assignments and adherence to confidentiality. Utilizes judgment and discretion in dealing with confidential and sensitive matters and materials.

Compensation: $22/hr
ESSENTIAL RESPONSIBILITIES: Responsible for ensuring compliance-related content is up -to-date and accurate on PPLM's external facing website and all internal and documentation platforms. Provides support related to compliance initiatives and facilitates compliance meetings as needed. Supports the coordination of organizational efforts to attain and maintain accreditation and licensure by designated oversight bodies. Provides oversight assistance in the timely and accurate preparation and submission of PPFA Accreditation documents Maintains Risk & Quality Management Workplan and Mandatory External Reports documentation Supports the implementation of compliance related training materials. Facilitates internal and external communications related to the simulated phishing program Monitors completion of any staff retraining requirements Performs routine or ad-hoc compliance-related audits and assists with corrective actions as needed Prepares and coordinates meetings and materials including minutes for internal and Board-level committees and meetings. Attends Board meetings as needed Coordinates and supports compliance related communications and employee engagement activities such as Compliance Week. Coordinates implementation and maintenance of corporate policy and procedure inventory. Edits and updates compliance related policies and procedures in collaboration with the Director of Compliance. Supports and assists with HIPAA privacy and security investigations and breach notifications. Enters compliance and security incidents into tracking databases and logs. Assists with corrective plan monitoring Assists and tracks responses to regulatory inquiries Tracks and maintains compliance and regulatory documentation as needed Provides administrative support to the Director of Compliance. Manages contract tracker to make sure all contracts/agreements are up to standard and all required information is available and accurate Other tasks and responsibilities as needed. Participation in PPLM's efforts to achieve goals for productivity. A commitment to PPLM's mission and values.
QUALIFICATIONS: BA/BS degree in Healthcare Administration/Management or equivalent experience Three years of experience in an administrative, operational support role preferred Must be goal-oriented with prior track record of meeting goals and following through, preferably in a clinical setting Ability to work effectively with staff of all levels within the organization. Self-directed and highly motivated Advanced knowledge of PC and information systems. Ability to organize and maintain multiple office systems and projects efficiently Ability to perform well under pressure, exercise maturity in judgment and communicate information effectively verbally and in writing. Ability to manage high volume workload consistently and efficiently. Strong excel skills preferred. Demonstrated ability to work with people of different races, ethnicities, sexual and gender identities and expressions, ages, abilities, and experiences Commitment to addressing the impact of racism and other oppressions on sexual healthA commitment to PPLM's mission and values
Planned Parenthood League of Massachusetts offers a comprehensive benefit package which includes; health, dental and vision insurance, 11 paid holidays, 403B retirement plan with a 3% employer match, paid parental leave, paid time off, flexible spending accounts and more.

Planned Parenthood League of Massachusetts is an equal employment opportunity employer and is committed to maintaining a non-discriminatory work environment, 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. Planned Parenthood is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation.

We are currently looking to fill a Biotech Production Compliance Coordinator position with a 1st shift, Monday-Friday, 8:00am - 4:30pm schedule. This position performs compliance related tasks associated with the change management process (change controls, corrective and preventative actions, and document workflows) to support manufacturing operations.
In this role, a typical day might include the following:

Independently prepares compliance documentation required to implement corrective actions and changes to various GMP processes in support of manufacturing operations, and in accordance with cGMP standards and written procedures. Performing administrative tasks to support manufacturing operations, as needed in accordance with cGMP standards and in compliance with written procedures. Processing quality instances (change controls, CAPAs, workflows) in quality systems (DocCompliance; ProcessCompliance) to update controlled documents and systems in accordance with cGMP standards. Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures. Facilitating or participating in cross-functional meetings to support the implementation of Corrective and Preventative Actions (CAPA's) and process improvements. Independently monitoring and progressing multiple projects concurrently; identifying, addressing, and/or raising potential obstacles in a timely manner. Documenting all training. Assisting with the training of new employees. Ensuring all tasks are performed in a manner consistent with safety standards.

This role might be for you if you:

Excel in a quality driven organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills. Have an attention to detail. Have strong technical writing and interpersonal communication skills. Can learn and apply computerized systems for the performance of daily tasks. Have experience navigating a controlled quality system (preferred but not required).

To be considered for this role, you must hold of the following education and/or work experience:

Level II: Bachelor's degree, preferably in Life Sciences or a related field, or

AS/AAS Degree in Biotechnology/Biological Science and 0-2 years of relevant work experience

Level III: Requires BS/BA in Life Sciences, or related field and 2 years of

relevant experience or equivalent combination of education and experience

Sr Level: Requires BS/BA in Life Sciences, or related field and 5 years of

relevant experience or equivalent combination of education and experience

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.